Identity
- Trade Name
- Diacap® FDA UDI
- Generic Name
- Haemodialysis system dialysate pyrogen filter FDA UDI
- Device Name
- DIACAP ULTRA DF FILTER CA & US FDA UDI
- Model / Reference
- 7107368 FDA UDI
- Description
- DIACAP ULTRA DF FILTER CA & US FDA UDI
Identifiers
- Catalog Number
- 7107368 FDA UDI
- Primary DI / UDI-DI
- 04046963178116 FDA UDI
- FDA Product Code
- FKQ FDA UDI
- GMDN Term
- Haemodialysis system dialysate pyrogen filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Category: Haemodialysis system dialysate pyrogen filter
Diacap® by B.Braun Avitum AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system dialysate pyrogen filter.
- Filter for dialysate purification — NIKKISO CO., LTD. · Class II
- Nipro Ultrafilter — NIPRO MEDICAL CORPORATION · Class II
- MarCor ENX Hollow Fiber Capsule UltraFilter — NEPHROS, INC. · Class II
- Diasafe — Fresenius Medical Care · Class II
- TQE Plus Endotoxin 10" Filter Flat 222 Head — NEPHROS, INC. · Class II
- DIASAFE®plusUS — Fresenius Medical Care Renal Therapies Group, LLC · Class II
- Nephros SSUmini JG UltraFiltro — NEPHROS, INC. · Class II
- TQE Plus Endotoxin 20" Filter Flat 222 Head — NEPHROS, INC. · Class II
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
- B.Braun Avitum AG
Sources (1)
- FDA UDI c8786288-b6ab-47c3-9223-00f1371662e4 36 fields · synced May 30, 2026