Manufacturer Profile
Fresenius Medical Care Holdings, Inc. Registered Devices
Listing registered devices, PMA filings, and compliance records for Fresenius Medical Care Holdings, Inc..
gudid
Disposable Set - 20 ft patient line, 20 ft drain line, 4 solution lines, 2 stay-safe PIN connectors
ID: 050-87226
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gudid
Disposable Set - 10 ft patient line, 4 ft drain line, 3 solution lines, 1 stay-safe PIN connector
ID: 050-87224
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gudid
Disposable Set - 20 ft patient line, 20 ft drain line, 3 solution lines, 1 stay-safe PIN connector
ID: 050-87225
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gudid
NaturaLyte Dry Pack Sodium Bicarbonate RX 12 bag; NaturaLyte Dry Bicarbonate Concentrate (08-4112-2)
ID: 08-4112-2
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gudid
F210 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 2.2 m2 / Ebeam / Single Use / 124 mL
ID: 0500421E
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gudid
F190 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 105 mL
ID: 0500419E
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gudid
F180 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.6 m2 / Ebeam / Single Use / 89 mL
ID: 0500418E
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gudid
F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single Use / 77 mL
ID: 0500416E
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gudid
F250NR Optiflux Dialyzer / High Flux / Polysulfone / 2.5 m2 / Ebeam / Single Use / 142 mL
ID: 0500325E
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gudid
F200NR Optiflux Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 113 mL
ID: 0500320E
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gudid
F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / Ebeam / Single Use / 102 mL
ID: 0500318E
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gudid
F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL
ID: 0500316E
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gudid
F200NR Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Single Use / 113 mL
ID: 0500320N
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gudid
F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / ETO / Single Use / 97 mL
ID: 0500318N
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gudid
F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / ETO / Single Use / 84 mL
ID: 0500316N
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gudid
F200A Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Multiple Use / 113 mL
ID: 0500320A
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gudid
F180A Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 99 mL
ID: 0500318A
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gudid
F18NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.8 m2 / Ebeam / Single Use / 103 mL
ID: 0500308E
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gudid
F16NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 84 mL
ID: 0500306E
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gudid
F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL
ID: 0500154A
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gudid
F60A Hemoflow Dialyzer / High Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL
ID: 0500136A
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gudid
F8 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL
ID: 0500164A
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gudid
F6 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL
ID: 0500145A
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gudid
F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Single Use / 45 mL
ID: 0520161A
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gudid
F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Single Use / 26 mL
ID: 0520165A
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enforcement
Bicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G, and RFP-456-G;
ID: Z-2321-2026
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enforcement
Optiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
ID: Z-0041-2026
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