Identity
- Trade Name
- CLEARLINK/BURETROL FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Large Bore Stopcock with Rotating Male Luer Lock Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar FDA UDI
- Model / Reference
- 3C0157 FDA UDI
- Description
- BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar, Large Bore Stopcock with Rotating Male Luer Lock Extension Set, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar FDA UDI
Identifiers
- Catalog Number
- 3C0157 FDA UDI
- Primary DI / UDI-DI
- 00085412073415 FDA UDI
- 510(k) Number
- K123874 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electric infusion pump administration set, single-use
Clearlink/Buretrol by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123874 also covers:
- CLEARLINK/BURETROL — BAXTER INTERNATIONAL INC.
- CLEARLINK/BURETROL — BAXTER INTERNATIONAL INC.
- CLEARLINK/BURETROL — BAXTER INTERNATIONAL INC.
- CLEARLINK/BURETROL — BAXTER INTERNATIONAL INC.
- CLEARLINK/BURETROL — BAXTER INTERNATIONAL INC.
- INTERLINK/BURETROL — BAXTER INTERNATIONAL INC.
- INTERLINK/BURETROL — BAXTER INTERNATIONAL INC.
- INTERLINK/BURETROL — BAXTER INTERNATIONAL INC.
- INTERLINK/BURETROL — BAXTER INTERNATIONAL INC.
- INTERLINK/BURETROL — BAXTER INTERNATIONAL INC.
- CLEARLINK/BURETROL — Baxter Healthcare Corp
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 f7d97176-421c-46c7-bbc8-62eb8776751a 36 fields · synced Jun 8, 2026