Identity
- Trade Name
- CLEARLINK/CONTINU-FLO FDA UDI
- Generic Name
- Intravenous line filter FDA UDI
- Device Name
- CONTINU-FLO Solution Set, 0.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar FDA UDI
- Model / Reference
- ACT8570 FDA UDI
- Description
- CONTINU-FLO Solution Set, 0.2 Micron Downstream Filter, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar FDA UDI
Identifiers
- Catalog Number
- ACT8570 FDA UDI
- Primary DI / UDI-DI
- 00085412079677 FDA UDI
- 510(k) Number
- K153158 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Intravenous line filter 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 filter
Clearlink/Continu-Flo 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
K153158 also covers:
- CLEARLINK — BAXTER INTERNATIONAL INC.
- CLEARLINK — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- CLEARLINK/DUO-VENT — BAXTER INTERNATIONAL INC.
- CLEARLINK/DUO-VENT — BAXTER INTERNATIONAL INC.
- INTERLINK — BAXTER INTERNATIONAL INC.
- INTERLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- INTERLINK/CONTINU-FLO — BAXTER INTERNATIONAL INC.
- INTERLINK/DUO-VENT — 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 03ec44b9-e311-4d33-ab35-95895447e4f3 36 fields · synced May 30, 2026