Identity
- Trade Name
- CLEARLINK/BURETROL FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar FDA UDI
- Model / Reference
- 2H8864 FDA UDI
- Description
- Non-DEHP BURETROL Solution Set, 150 mL Burette Drip Chamber Filter Valve, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar FDA UDI
Identifiers
- Catalog Number
- 2H8864 FDA UDI
- Primary DI / UDI-DI
- 00085412071749 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
Similar devices
Also classified as Electric infusion pump administration set, single-use.
- MODD1 Infusion Set, 10 Pack — Modular Medical, Inc. · Class II
- CompuDent-STA™ Drive Unit — MILESTONE SCIENTIFIC, INC. · Class II
- Clear-View Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- Alaris, SmartSite — BD Switzerland Sàrl · Class II
- Clear-View Multi-site Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- CADD — ICU MEDICAL, INC. · Class II
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC · Class II
- Infusomat® — B. BRAUN MEDICAL INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Baxter International Inc.
Sources (1)
- FDA UDI a1540ba0-75fe-44ea-b318-0dc87822c7b0 36 fields · synced May 30, 2026