Identity
- Trade Name
- 5008X Hemodialysis Machine FDA UDI
- Generic Name
- Haemodialysis system, institutional FDA UDI
- Device Name
- 5008X CAREsystem with CLiC and CDX FDA UDI
- Model / Reference
- M204441 FDA UDI
- Description
- 5008X CAREsystem with CLiC and CDX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840861102433 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 Hemodialysis Machine by Fresenius Medical Care Renal Therapies Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemodialysis system, institutional.
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- Molded Products, Inc. — MOLDED PRODUCTS INC. · Class II
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Cleared under the same submission
K231534 also covers:
- 5008X Fluid Sampling Accessory — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X HDF Hemodialysis Blood Tubing Set — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X HDF Hemodialysis Blood Tubing Set with Access Flow Reversing Connector (Tw — Fresenius Medical Care Renal Therapies Group, LLC
- 5008X HDF Hemodialysis Blood Tubing Set with CLiC Blood Chamber — Fresenius Medical Care Renal Therapies Group, LLC
- CitraSure™ — Fresenius Medical Care Renal Therapies Group, LLC
K243505 also covers:
- 5008X — Fresenius Medical Care
- 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
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 Renal Therapies Group, LLC
Sources (1)
- FDA UDI ee2be037-2d7d-4f05-8545-d9d1f98f5e17 35 fields · synced May 30, 2026