Identity
- Trade Name
- CLEARLINK/CONTINU-FLO/DUO-VENT FDA UDI
- Generic Name
- Basic intravenous administration set, noninvasive FDA UDI
- Device Name
- CLEARLINK System Solution Set with DUO-VENT Spike FDA UDI
- Model / Reference
- 2R8538 FDA UDI
- Description
- CLEARLINK System Solution Set with DUO-VENT Spike FDA UDI
Identifiers
- Catalog Number
- 2R8538 FDA UDI
- Primary DI / UDI-DI
- 00085412676647 FDA UDI
- 510(k) Number
- K180739 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Basic intravenous administration set, noninvasive 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
No
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
Dimensions & Sizes
- Size
- Length — 119 Inch FDA UDITotal Volume — 13 Milliliter FDA UDI
Category: Basic intravenous administration set, noninvasive
Clearlink/Continu-Flo/Duo-Vent by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Basic intravenous administration set, noninvasive.
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- Kew Medical — DOUGLAS MEDICAL PRODUCTS, INC · Class II
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Cleared under the same submission
K180739 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/DUO-VENT — BAXTER INTERNATIONAL INC.
- CLR1 - CLEARLINK — BAXTER INTERNATIONAL INC.
- CLEARLINK/CONTINU-FLO/DUO-VENT — Baxter Healthcare Corp
- CLEARLINK/CONTINU-FLO/DUO-VENT — Baxter Healthcare Corp
- CLEARLINK/DUO-VENT — Baxter Healthcare Corp
- CLEARLINK/DUO-VENT — Baxter Healthcare Corp
- DUO - DUO-VENT — 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 Healthcare Corp
Sources (1)
- FDA UDI a57d4d58-b687-428c-90ca-26837ed56bb1 37 fields · synced Jun 8, 2026