Identity
- Trade Name
- CLEARLINK FDA UDI
- Generic Name
- Medication transfer set FDA UDI
- Device Name
- Luer Activated Universal Vial Adapter FDA UDI
- Model / Reference
- 2N8395 FDA UDI
- Description
- Luer Activated Universal Vial Adapter FDA UDI
Identifiers
- Catalog Number
- 2N8395 FDA UDI
- Primary DI / UDI-DI
- 00085412046419 FDA UDI
- 510(k) Number
- K924064 FDA UDI
- FDA Product Code
- LHI FDA UDI
- GMDN Term
- Medication transfer set 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: Medication transfer set
Clearlink 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
K924064 also covers:
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 ca5956f2-afec-463d-b8bb-72152f734a05 36 fields · synced Jun 6, 2026