Identity
- Trade Name
- PRISMAFLEX SET FDA UDI
- Generic Name
- Haemofilter FDA UDI
- Device Name
- Disposable extracorporeal circuit FDA UDI
- Model / Reference
- 107636US FDA UDI
- Description
- Disposable extracorporeal circuit FDA UDI
Identifiers
- Catalog Number
- 107636US FDA UDI
- Primary DI / UDI-DI
- 00085412954073 FDA UDI
- 510(k) Number
- K212216 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemofilter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemofilter
Prismaflex Set by Gambro Industries — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PRISMAFLEX SET — GAMBRO INDUSTRIES · Class II
- PRISMAFLEX SET — GAMBRO INDUSTRIES · Class II
Cleared under the same submission
K212216 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gambro Industries
Sources (1)
- FDA UDI 53d04d30-3f97-4171-a131-fa1bf3e34081 37 fields · synced May 31, 2026