Identity
- Trade Name
- CLEARLINK FDA UDI
- Generic Name
- Intravenous line stopcock FDA UDI
- Device Name
- 3-Port Manifold with Check Valves, Large Bore Stopcock Extension Set with Rotating Male Luer Lock, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar FDA UDI
- Model / Reference
- 2C8921 FDA UDI
- Description
- 3-Port Manifold with Check Valves, Large Bore Stopcock Extension Set with Rotating Male Luer Lock, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar FDA UDI
Identifiers
- Catalog Number
- 2C8921 FDA UDI
- Primary DI / UDI-DI
- 00085412071718 FDA UDI
- FDA Product Code
- FMG FDA UDI
- GMDN Term
- Intravenous line stopcock FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravenous line stopcock
Clearlink by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ICU Medical — ICU MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class II
- SmartSite — BD Switzerland Sàrl · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI dcb14567-4a5c-4db6-b428-7d2cbbd853ce 35 fields · synced May 30, 2026