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Product Classification / EMDN Category

FDA Product Code: All lots

Directory of devices assigned to product classification code All lots.

enforcement Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308 Manufacturer: Siemens Healthcare Diagnostics, Inc
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enforcement Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85 Manufacturer: Datascope Corp.
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enforcement Stryker Neurovascular, AXS Infinity LS Plus Long Sheath, Rx Only, Sterile EO, USA Customer Service 855-91 NEURO (916-3876): a) REF: INC-11196-70, 70cm, b) REF: INC-11196-80, 80cm, c) REF: INC-11196-90, 90cm Product Usage: Indications for Use: The AXS Infinity LS Plus Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature. Device Description: The AXS Infinity LS Plus Long Sheath is a single lumen, flexible, variable stiffness long sheath with an 0.091 inch inner diameter. It has a radiopaque marker band on the distal end and a Luer hub at the proximal end. The AXS Infinity LS Plus Long Sheath shaft has a 10 cm lubricious coating at the distal end to reduce friction during use. The inner lumen of the AXS Infinity LS Plus Long Sheath is compatible with 6F or smaller catheters. Each package includes one AXS Infinity LS Plus Long Sheath (INC- 11196-70, INC-11196-80, or INC-11196-90), one Dilator, and one hemostasis valve. Dimensions of the AXS Infinity LS Plus Long Sheath are included on the individual device label. Manufacturer: Stryker Neurovascular
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enforcement FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6 Manufacturer: 3M Company - Health Care Business
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enforcement Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration. Manufacturer: Cook Inc.
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enforcement Journey BCS Knee CoCr Femoral Components, Catalog Numbers: 74021210, 74021211, 74021212, 74021213, 74021214, 74021215, 74021216, 74021217, 74021218, 74021219, 74021220, 74021221, 74021222, 74021223, 74021224, 74021225, 74021226, 74021227, 74021228, 74021229 Manufacturer: Smith & Nephew, Inc.
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enforcement JOURNEY BCS Knee Conventional Polyethylene Inserts: 74023111, 74023112, 74023113, 74023114, 74023115, 74023116, 74023117, 74023118, 74023121, 74023122, 74023123, 74023124, 74023125, 74023126, 74023127, 74023128, 74023131, 74023132, 74023133, 74023134, 74023135, 74023136, 74023137, 74023138, 74023141, 74023142, 74023143, 74023144, 74023145, 74023146, 74023147, 74023148, 74023211, 74023212, 74023213, 74023214, 74023215, 74023216, 74023217, 74023218, 74023221, 74023222, 74023223, 74023224, 74023225, 74023226, 74023227, 74023228, 74023231, 74023232, 74023233, 74023234, 74023235, 74023236, 74023237, 74023238, 74023241, 74023242, 74023243, 74023244, 74023245, 74023246, 74023247, 74023248, 74023251, 74023252, 74023253, 74023254, 74023255, 74023256, 74023257, 74023258, 74023261, 74023262, 74023263, 74023264, 74023265, 74023266, 74023267, 74023268, 74023271, 74023272, 74023273, 74023274, 74023275, 74023276, 74023277, 74023278, 74023281, 74023282, 74023283, 74023284, 74023285, 74023286, 74023287, 74023288, 74023311, 74023312, 74023313, 74023314, 74023315, 74023316, 74023317, 74023318, 74023321, 74023322, 74023323, 74023324, 74023325, 74023326, 74023327, 74023328, 74023331, 74023332, 74023333, 74023334, 74023335, 74023336, 74023337, 74023338, 74023341, 74023342, 74023343, 74023344, 74023345, 74023346, 74023347, 74023348, 74023411, 74023412, 74023413, 74023414, 74023415, 74023416, 74023417, 74023418, 74023421, 74023422, 74023423, 74023424, 74023425, 74023426, 74023427, 74023428, 74023431, 74023432, 74023433, 74023434, 74023435, 74023436, 74023437, 74023438, 74023441, 74023442, 74023443, 74023444, 74023445, 74023446, 74023447, 74023448, 74023451, 74023452, 74023453, 74023454, 74023455, 74023456, 74023457, 74023458, 74023461, 74023462, 74023463, 74023464, 74023465, 74023466, 74023467, 74023468, 74023471, 74023472, 74023473, 74023474, 74023475, 74023476, 74023477, 74023478, 74023481, 74023482, 74023483, 74023484, 74023485, 74023486, 74023487, 74023488, 74023648, 74203326 Manufacturer: Smith & Nephew, Inc.
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enforcement (1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706 Manufacturer: DePuy Orthopaedics, Inc.
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enforcement AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255NAIL TIB DYN 08X25.5 - STERILE 800508270NAIL TIB DYN 08X27.0 - STERILE 800508285NAIL TIB DYN 08X28.5 - STERILE 800508300NAIL TIB DYN 08X30.0 - STERILE 800508315NAIL TIB DYN 08X31.5 - STERILE 800508330NAIL TIB DYN 08X33.0 - STERILE 800508345NAIL TIB DYN 08X34.5 - STERILE 800508360NAIL TIB DYN 08X36.0 - STERILE 800508375NAIL TIB DYN 08X37.5 - STERILE 800508390NAIL TIB DYN 08X39.0 - STERILE 800508405NAIL TIB DYN 08X40.5 - STERILE 800508420NAIL TIB DYN 08X42.0 - STERILE 800509255NAIL TIB DYN 09X25.5 - STERILE 800509270NAIL TIB DYN 09X27.0 - STERILE 800509285NAIL TIB DYN 09X28.5 - STERILE 800509300NAIL TIB DYN 09X30.0 - STERILE 800509315NAIL TIB DYN 09X31.5 - STERILE 800509330NAIL TIB DYN 09X33.0 - STERILE 800509345NAIL TIB DYN 09X34.5 - STERILE 800509360NAIL TIB DYN 09X36.0 - STERILE 800509375NAIL TIB DYN 09X37.5 - STERILE 800509390NAIL TIB DYN 09X39.0 - STERILE 800509405NAIL TIB DYN 09X40.5 - STERILE 800509420NAIL TIB DYN 09X42.0 - STERILE 800510255NAIL TIB DYN 10X25.5 - STERILE 800510270NAIL TIB DYN 10X27.0 - STERILE 800510285NAIL TIB DYN 10X28.5 - STERILE 800510300NAIL TIB DYN 10X30.0 - STERILE 800510315NAIL TIB DYN 10X31.5 - STERILE 800510330NAIL TIB DYN 10X33.0 - STERILE 800510345NAIL TIB DYN 10X34.5 - STERILE 800510360NAIL TIB DYN 10X36.0 - STERILE 800510375NAIL TIB DYN 10X37.5 - STERILE 800510390NAIL TIB DYN 10X39.0 - STERILE 800510405NAIL TIB DYN 10X40.5 - STERILE 800510420NAIL TIB DYN 10X42.0 - STERILE 800511270NAIL TIB DYN 11X27.0 - STERILE 800511285NAIL TIB DYN 11X28.5 - STERILE 800511300NAIL TIB DYN 11X30.0 - STERILE 800511330NAIL TIB DYN 11X33.0 - STERILE 800511345NAIL TIB DYN 11X34.5 - STERILE 800511360NAIL TIB DYN 11X36.0 - STERILE 800511375NAIL TIB DYN 11X37.5 - STERILE 800511390NAIL TIB DYN 11X39.0 - STERILE 800511405NAIL TIB DYN 11X40.5 - STERILE 800511420NAIL TIB DYN 11X42.0 - STERILE 800512270NAIL TIB DYN 12X27.0 - STERILE 800512285NAIL TIB DYN 12X28.5 - STERILE 800512300NAIL TIB DYN 12X30.0 - STERILE 800512315NAIL TIB DYN 12X31.5 - STERILE 800512330NAIL TIB DYN 12X33.0 - STERILE 800512345NAIL TIB DYN 12X34.5 - STERILE 800512360NAIL TIB DYN 12X36.0 - STERILE 800512375NAIL TIB DYN 12X37.5 - STERILE 800512390NAIL TIB DYN 12X39.0 - STERILE 800512405NAIL TIB DYN 12X40.5 - STERILE 800512420NAIL TIB DYN 12X42.0 - STERILE 800513285NAIL TIB DYN 13X28.5 - STERILE 800513300NAIL TIB DYN 13X30.0 - STERILE 800513315NAIL TIB DYN 13X31.5 - STERILE 800513330NAIL TIB DYN 13X33.0 - STERILE 800513345NAIL TIB DYN 13X34.5 - STERILE 800513360NAIL TIB DYN 13X36.0 - STERILE 800513375NAIL TIB DYN 13X37.5 - STERILE 800513390NAIL TIB DYN 13X39.0 - STERILE 800513405NAIL TIB DYN 13X40.5 - STERILE 800513420NAIL TIB DYN 13X42.0 - STERILE Product Usage: A rod, when inserted into the intramedullary canal of the tibia, acts as an immobilization device to hold ends of a fractured bone in position. Manufacturer: Zimmer Biomet, Inc.
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enforcement Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acute and chronic renal failure during hemodialysis procedure. Manufacturer: Fresenius Medical Care Holdings, Inc.
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enforcement AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255NAIL TIB DYN 08 X 25.5 810508270NAIL TIB DYN 08 X 27.0 810508285NAIL TIB DYN 08 X 28.5 810508300NAIL TIB DYN 08 X 30.0 810508315NAIL TIB DYN 08 X 31.5 810508330NAIL TIB DYN 08 X 33.0 810508345NAIL TIB DYN 08 X 34.5 810508360NAIL TIB DYN 08 X 36.0 810508375NAIL TIB DYN 08 X 37.5 810508390NAIL TIB DYN 08 X 39.0 810508405NAIL TIB DYN 08 X 40.5 810508420NAIL TIB DYN 08 X 42.0 810509255NAIL TIB DYN 09 X 25.5 810509270NAIL TIB DYN 09 X 27.0 810509285NAIL TIB DYN 09 X 28.5 810509300NAIL TIB DYN 09 X 30.0 810509315NAIL TIB DYN 09 X 31.5 810509330NAIL TIB DYN 09 X 33.0 810509345NAIL TIB DYN 09 X 34.5 810509360NAIL TIB DYN 09 X 36.0 810509375NAIL TIB DYN 09 X 37.5 810509390NAIL TIB DYN 09 X 39.0 810509405NAIL TIB DYN 09 X 40.5 810509420NAIL TIB DYN 09 X 42.0 810510255NAIL TIB DYN 10 X 25.5 810510270NAIL TIB DYN 10 X 27.0 810510285NAIL TIB DYN 10 X 28.5 810510300NAIL TIB DYN 10 X 30.0 810510315NAIL TIB DYN 10 X 31.5 810510330NAIL TIB DYN 10 X 33.0 810510345NAIL TIB DYN 10 X 34.5 810510360NAIL TIB DYN 10 X 36.0 810510375NAIL TIB DYN 10 X 37.5 810510390NAIL TIB DYN 10 X 39.0 810510405NAIL TIB DYN 10 X 40.5 810510420NAIL TIB DYN 10 X 42.0 810511255NAIL TIB DYN 11 X 25.5 810511270NAIL TIB DYN 11 X 27.0 810511285NAIL TIB DYN 11 X 28.5 810511300NAIL TIB DYN 11 X 30.0 810511315NAIL TIB DYN 11 X 31.5 810511330NAIL TIB DYN 11 X 33.0 810511345NAIL TIB DYN 11 X 34.5 810511360NAIL TIB DYN 11 X 36.0 810511375NAIL TIB DYN 11 X 37.5 810511390NAIL TIB DYN 11 X 39.0 810511405NAIL TIB DYN 11 X 40.5 810511420NAIL TIB DYN 11 X 42.0 810512270NAIL TIB DYN 12 X 27.0 810512285NAIL TIB DYN 12 X 28.5 810512300NAIL TIB DYN 12 X 30.0 810512315NAIL TIB DYN 12 X 31.5 810512330NAIL TIB DYN 12 X 33.0 810512345NAIL TIB DYN 12 X 34.5 810512360NAIL TIB DYN 12 X 36.0 810512375NAIL TIB DYN 12 X 37.5 810512390NAIL TIB DYN 12 X 39.0 810512405NAIL TIB DYN 12 X 40.5 810512420NAIL TIB DYN 12 X 42.0 810513255NAIL TIB DYN 13 X 25.5 810513285NAIL TIB DYN 13MM X 28.5CM 810513300NAIL TIB DYN 13MMX30.0 CM 810513315NAIL TIB DYN 13MM X 31.5 CM 810513330NAIL TIB DYN 13 X 33.0 810513345NAIL TIB DYN 13MM X 34.5 CM 810513360NAIL TIB DYN 13 X 36.0 MM 810513375NAIL TIB DYN 13MM X 37.5 CM 810513390NAIL TIB DYN 13MMX39.0CM 810513405NAIL TIB DYN 13MM X 40.5 CM 810513420NAIL TIB DYN 13MM X 42 CM Product Usage: A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device. Manufacturer: Zimmer Biomet, Inc.
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enforcement Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 - Product Usage: The ADVIA Centaur Anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum and plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. [Note: the Atellica IM anti-CCP IgG (aCCP) assay was introduced for sale through the Replacement Reagent Policy.] Manufacturer: Siemens Healthcare Diagnostics, Inc
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enforcement Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Manufacturer: Varian Medical Systems, Inc.
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enforcement JOURNEY BCS OXINIUM Knee Femoral Components, Catalog Numbers: 74021110, 74021111, 74021112, 74021113, 74021114, 74021115, 74021116, 74021117, 74021118, 74021119, 74021120, 74021121, 74021122, 74021123, 74021124, 74021125, 74021126, 74021127, 74021128, 74021129, 74021130, 74021131, 74021132, 74021133, 74021134, 74021135, 74021136, 74021137, 74021138, 74021139, 74021140, 74021141, 74021142, 74021143, 74021144, 74021145, 74021146, 74021147, 74021148, 74021149 Manufacturer: Smith & Nephew, Inc.
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enforcement Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration. Manufacturer: Cook Inc.
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enforcement ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736, UPC 0 51131 20387 7 Manufacturer: 3M Company - Health Care Business
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enforcement 3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136 Manufacturer: 3M Company - Health Care Business
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enforcement Consult Diagnostics Eon Calcium Reagent For In-Vitro Diagnostic Use PN: 1429 For the quantitative measurement of calcium in plasma and serum Manufacturer: Vital Diagnostics, Inc.
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enforcement MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Manufacturer: The Anspach Effort, Inc.
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enforcement Biomet Screw Instrument Tray 6.5/80MM- Surgical Tray Product Code: 246111003 Manufacturer: Biomet
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enforcement Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235 Manufacturer: Biomet
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enforcement Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones. Manufacturer: Small Bone Innovations
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enforcement MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Manufacturer: The Anspach Effort, Inc.
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enforcement 45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031. Model #: P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01. The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill). Manufacturer: Greatbatch Medical
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enforcement Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Manufacturer: The Anspach Effort, Inc.
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enforcement MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy. Manufacturer: The Anspach Effort, Inc.
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enforcement Vital Diagnostics Envoy Calcium Reagent For In-Vitro Diagnostic Use. PN 55285 For the quantitative measurement of calcium in plasma and serum Manufacturer: Vital Diagnostics, Inc.
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enforcement Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy. Manufacturer: Varian Medical Systems, Inc.
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enforcement Fornier Phantom Fiber(TM) Sutures: Item NumberDescription SMB0004254.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB0005255.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP0004254.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP0005255.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMSB01101PK PHANTOM FIBER SZ 2 WHITE SMSB0110N lPK BIOFIBER SUTURE SZ 2 WHT NEEDLED SMSB011210 PK PHANTOM FIBER SZ 2 WHITE SMSB0112N 10 PK PHANTOM FIBER SUTURE SZ 2WHT NEEDLED SMSB01201PK PHANTOM FIBER SZ 2 VIOLET SMSB0120NlPK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB012210 PK PHANTOM FIBER SZ 2 VIOLET SMSB0122N10 PK BIOFIBER SUTURE SZ 2 VLT NEEDLED SMSB01301PK PHANTOM FIBER SZ 2 WHITE/VIOLET SMSB013210 PK PHANTOM FIBER SZ 2 WHITE/VIOLET Indications for use for the Phantom Fiber are: Phantom Fiber suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery. Manufacturer: Tornier, Inc
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enforcement Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-4323-5, 08-4325-1, 13-1251-1, 13-2201-5, 13-2231-2, 13-2251-0, 13-3231-1,13-3251-9, 13-4123-1' 13-4220-1, 13-4225-1 ' 13-4325-1. For the treatment of acute and chronic renal failure during hemodialysis procedure. Manufacturer: Fresenius Medical Care Holdings, Inc.
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enforcement VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Manufacturer: Draeger Medical, Inc.
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enforcement ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Manufacturer: Draeger Medical, Inc.
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enforcement VentStar Watertrap (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP00363 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Manufacturer: Draeger Medical, Inc.
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enforcement VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Manufacturer: Draeger Medical, Inc.
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enforcement MAHURKAR and Argyle acute hemodialysis catheters, Material numbers 8813793009 8813793013 8813794005 8813794009 8813816005 8813816009 8813817005 8813817009 8815668007 8815668011 8815668021 8815668027 8817142005 8817143005 8817145005 8817146001 8817146007 8817149007 8817232018 8817232019 8817277007 8817277011 8817277021 8817277027 8830414001 8830414002 8830415001 8830415003 8830416001 8830416003 8830416021 8830416023 8831173010 8831173011 8831173012 8831661001 8831662001 8831663001 8831663002 8831663021 8831663022 8832539001 8832539002 8832539003 8832539006 8832539007 8888115132 8888115133 8888115162 8888115163 8888115192 8888115193 8888115242 8888115243 8888135131 8888135132 8888135133 8888135134 8888135135 8888135136 8888135137 8888135138 8888135139 8888135140 8888135141 8888135142 8888135161 8888135162 8888135163 8888135164 8888135165 8888135166 8888135167 8888135168 8888135191 8888135192 8888135193 8888135194 8888135195 8888135196 8888135197 8888135198 8888135241 8888135242 8888135243 8888135244 8888135245 8888135246 8888135247 8888135248 8888340629 8888340637 8888345504 8888345512 8888345520 8888345538 8888345603 8888345611 8888345629 8888345637 8888101001HP 8888101002HP 8888101003HP 8888101004HP 8888102003HP 8888102004HP 8888103001HP 8888103002HP 8888103003HP 8888103004HP 8888104003HP 8888104004HP 8888340629HP 8888340637HP 8888345504HP 8888345512HP 8888345520HP 8888345538HP 8888345603HP 8888345611HP 8888345629HP 8888345637HP Manufacturer: COVIDIEN LLC
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enforcement 8mm FlexDex Needle Driver, Product Code FD-335 ND Manufacturer: FlexDex Inc.
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enforcement Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field. Manufacturer: Mar-Med Co
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enforcement Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65 Manufacturer: Datascope Corp.
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enforcement Depuy Spine Side Fire Needles 11G X 4IN, part of the Confidence Spinal Cement System Product Code: 283904411. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.
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enforcement Depuy Spine Side Fire Needles 13G X 6IN, part of the Confidence Spinal Cement System Product Code 283904613. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.
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enforcement Depuy Spine Side Fire Needles 13G X 4IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904413. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.
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enforcement Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle. Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120 Manufacturer: Instrumentation Laboratory Co.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Manufacturer: DePuy Spine, Inc.
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enforcement HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320 Manufacturer: Instrumentation Laboratory Co.
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enforcement Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Manufacturer: Synthes USA HQ, Inc.
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enforcement DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Manufacturer: DePuy Spine, Inc.
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enforcement Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R Manufacturer: Covidien LLC
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enforcement Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body, Part Number 04.631.500 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Manufacturer: Synthes USA HQ, Inc.
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enforcement SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380. The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure. Manufacturer: Intuitive Surgical, Inc.
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enforcement Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA Centaur CP systems. Manufacturer: Siemens Healthcare Diagnostics, Inc
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enforcement AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests. Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine Manufacturer: Medscience Inc
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enforcement Lipase, Catalog No. OSR6x30 Product Usage: Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers. Manufacturer: Beckman Coulter Inc.
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enforcement Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile. Manufacturer: Orthofix, Inc
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enforcement DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement ST AIA-PACK PROG II, Progesterone II Assay, Part Number: 025239 Manufacturer: Tosoh Bioscience Inc
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enforcement Medtronic AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter, 540 The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY(R) NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration. Manufacturer: Medtronic Perfusion Systems
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enforcement Flexible Shaft hip and anatomical shoulder instrument used for preparation of bone in Trauma, Hip and Shoulder surgeries.; Model Number: 75.80.04 Manufacturer: Zimmer Biomet, Inc.
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enforcement Lactate, Catalog No. OSR6x93 Product Usage: Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers. Manufacturer: Beckman Coulter Inc.
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enforcement SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361. The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure. Manufacturer: Intuitive Surgical, Inc.
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enforcement Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440 Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement The BD Vacutainer Plus Plastic Citrate Blood Collection Tube is an evacuated blood collection tube that provides a means of collecting, transporting, and processing blood in a closed tube. The buffered sodium citrate additive provides an anticoagulated specimen that may be used for clinical laboratory coagulation assays. Manufacturer: Becton Dickinson & Company
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enforcement DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component. Manufacturer: DePuy Spine, Inc.
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enforcement Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Product Number: 10327382 (Mfr: Sekisui Diagnostics) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement BD Vacutainer EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551) Manufacturer: Becton Dickinson & Company
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enforcement HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220 Manufacturer: Instrumentation Laboratory Co.
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enforcement IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832, 10381142 Product Usage: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various hormonal sexual disorders Manufacturer: Siemens Healthcare Diagnostics, Inc
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enforcement IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 10381178, 10702833, 10381177, 10702834 Product Usage: For in vitro diagnostic use the IMMULITE2000 systems Analyzers- for the quantitative measurement of estradiol in serum, as an aid in the diagnosis and treatment of various sexual disorders Manufacturer: Siemens Healthcare Diagnostics, Inc
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enforcement Cholesterol, Catalog No. OSR6x16 Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers. Manufacturer: Beckman Coulter Inc.
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enforcement Triglyceride, Catalog No. OSR6x118 Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers. Manufacturer: Beckman Coulter Inc.
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enforcement DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct. Manufacturer: DePuy Spine, Inc.
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enforcement Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception). Manufacturer: Gyrus Acmi, Incorporated
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enforcement Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The E2 method is an in vitro diagnostic test for the quantitative measurement of estradiol in human serum and plasma on the Dimension VistaSystem. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy. Manufacturer: Siemens Healthcare Diagnostics, Inc
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enforcement Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing. Manufacturer: Beckman Coulter Inc.
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enforcement Medtronic TRILLIUM AFFINITY NT, Cardiotomy/Venous Reservoir (CVR) with Filter,with Trillium Biosurface, 540T The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with Filter is a single used device designed to collect and store blood during extracorporeal circulation. Venous blood is collected and de foamed while cardiotomy blood is collected, de foamed and filtered before mixing with the venous blood. The AFFINITY NT Cardiotomy/Venous Reservoir (CVR) with filter is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures for up to 6 hours in duration. Manufacturer: Medtronic Perfusion Systems
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enforcement ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (heparin or EDTA). Product Number: 10286035 (Mfr: Randox Laboratories) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. (Product Numbers: 10318168, 10309500), ALT P5P (Part Numbers: 10318168/10326245, 10309500/10315181), and ALT Concentrated (Part Numbers: 10283341, 10283341, 10283342); (Mfr: Randox Laboratories) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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enforcement Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Healthcare Diagnostics, Newark, DE) Manufacturer: Siemens Healthcare Diagnostics, Inc.
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