Identity
- Trade Name
- Diasafe FDA UDI
- Generic Name
- Haemodialysis system dialysate pyrogen filter FDA UDI
- Device Name
- FILTER, DIASAFE PLUS FDA UDI
- Model / Reference
- 5008201 FDA UDI
- Description
- FILTER, DIASAFE PLUS FDA UDI
Identifiers
- Catalog Number
- 5008203 FDA UDI
- Primary DI / UDI-DI
- 04039361001384 FDA UDI
- 510(k) Number
- K944767 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Haemodialysis system dialysate pyrogen filter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Dimensions & Sizes
- Size
- Area/Surface Area — 2.2 Square meter FDA UDI
Category: Haemodialysis system dialysate pyrogen filter
Diasafe by Fresenius Medical Care — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system dialysate pyrogen filter.
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- DIASAFE®plusUS — Fresenius Medical Care Renal Therapies Group, LLC · Class II
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- 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 |
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Manufacturer
- Manufacturer
- Fresenius Medical Care
Sources (1)
- FDA UDI 72fc770e-4a9f-4dec-8c14-4ba17a1c761d 38 fields · synced May 29, 2026