Identity
- Trade Name
- 5008X FDA UDI
- Generic Name
- Haemodialysis system, institutional FDA UDI
- Device Name
- 5008X + CLiC FDA UDI
- Model / Reference
- M204421 FDA UDI
- Description
- 5008X + CLiC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840861102877 FDA UDI
- 510(k) Number
- K243505 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis system, institutional 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Haemodialysis system, institutional
5008x by Fresenius Medical Care — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system, institutional.
- B.BRAUN — B.Braun Avitum AG · Class I
- Prismaflex — Gambro, Inc. · Class II
- 2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
- B.BRAUN — B.Braun Avitum AG · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
Cleared under the same submission
K243505 also covers:
- 5008X — Fresenius Medical Care
- 5008X — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Blood Pressure Cuff — Fresenius Medical Care
- Support plate — Fresenius Medical Care
- Top Tray — Fresenius Medical Care
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X — Fresenius Medical Care Renal Therapies Group, LLC
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
- Fresenius Medical Care
Sources (1)
- FDA UDI f156c8e1-38db-46bb-8c38-1ca106d51a8d 35 fields · synced Jun 6, 2026