Rusch Care CrystalClear Plus, C Tracheostomy Tube Set (UDI 04026704109784)
Manufactured by Teleflex Medical
Device Regulatory Overview
The Rusch Care CrystalClear Plus, C Tracheostomy Tube Set (Model/Catalog Number: 858603-000080) is a medical device manufactured by Teleflex Medical. This product is indexed under FDA Product Code / Category Classification R0105020101 within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- 858603-000080
- Product Code / EMDN
- R0105020101
- Device Name
- TRACHEOST. TUBE W. CUFF, 15MM CONN.
- Database Sync Date
- 2026-08-09 16:28:59
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Rusch Care CrystalClear Plus, C Tracheostomy Tube Set?
The registered manufacturer of record for Rusch Care CrystalClear Plus, C Tracheostomy Tube Set is Teleflex Medical.
What is the Primary UDI-DI identifier for Rusch Care CrystalClear Plus, C Tracheostomy Tube Set?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04026704109784.
What classification code is assigned to this device?
This device is registered under product classification code R0105020101.
Similar Classification Devices (R0105020101)
Other Devices by Teleflex Medical
- → ARROW OnControl Bone Marrow Biopsy System Tray, Sterile, Rx only, Manufactured for: Teleflex Medical, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients
- → CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. Product Code: 833-137.
- → WECK Visistat 35R Disposable Skin Stapler, Ref 528135, Rx Only, Sterile EO, Visistat is indicated for the external skin closure of lacerations on the outer layer of the dermis for a wide range of general, thoracic, obstetric, gynecological, orthopedic, cardiovascular, urological, and plastic surgical procedures
- → INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
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