Identity
- Trade Name
- NXSTAGE CARTRIDGE EXPRESS EUDAMEDFDA UDI
- Generic Name
- Haemodialysis/haemofiltration system component set FDA UDI
- Model / Reference
- CAR-170-C EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- M535CAR170C0 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M535CAR170C0 EUDAMED
- FDA Product Code
- KDI FDA UDI
- EMDN Code
- F01060303 DIALYSERS - UFC > 35 ml/h/mmHg, SYNTHETIC MEMBRANES EUDAMED
- GMDN Term
- Haemodialysis/haemofiltration system component set FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5860 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Nxstage Cartridge Express by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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
- NxStage Medical, Inc.
Sources (2)
- FDA UDI ffad95a8-c1dd-4d62-bef1-0171a87e84a3 34 fields · synced Oct 7, 2026
- EUDAMED 5898ae77-55ab-47a0-85e6-ff134f1122f2 61 fields · synced Jul 12, 2026