Identity
- Trade Name
- CLEARLINK/CONTINU-FLO FDA UDI
- Generic Name
- Intravenous line stopcock FDA UDI
- Device Name
- CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter, Large Bore Stopcock Manifold Extension Set, Luer Activated Valve, Male Luer Lock Adapter, Extension Set, Male Luer Lock Adapter with Retractable Collar FDA UDI
- Model / Reference
- 3C0162 FDA UDI
- Description
- CONTINU-FLO Solution Set, 2 Luer Activated Valves, Male Luer Lock Adapter, Large Bore Stopcock Manifold Extension Set, Luer Activated Valve, Male Luer Lock Adapter, Extension Set, Male Luer Lock Adapter with Retractable Collar FDA UDI
Identifiers
- Catalog Number
- 3C0162 FDA UDI
- Primary DI / UDI-DI
- 00085412076294 FDA UDI
- 510(k) Number
- K130245 FDA UDI
- FDA Product Code
- FMG FDA UDIFPA 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intravenous line stopcock
Clearlink/Continu-Flo by Baxter International Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intravenous line stopcock.
- Stopcocks — Argon Medical Devices, Inc. · Class II
- Medex — ICU MEDICAL, INC. · Class II
- Kabi Access Infusion Sets — CODAN US Corporation · Class II
- SPC-4(4-WAY STOPCOCK) — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- VYGON — Vygon Corp. · Class II
- SmartSite — BD Switzerland Sàrl · Class II
Cleared under the same submission
K130245 also covers:
- CLEARLINK — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- INTERLINK — BAXTER INTERNATIONAL INC.
- INTERLINK — BAXTER INTERNATIONAL INC.
- INTERLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- INTERLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- INTERLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
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 554154d9-4397-4004-bc2c-d7d631e09465 36 fields · synced May 30, 2026