Identity
- Trade Name
- CLEANCART A EUDAMEDCLCA - CLEANCART A FDA UDI
- Generic Name
- Sodium carbonate haemodialysis system cleaning cartridge FDA UDI
- Device Name
- CleanCart A EUDAMEDFDA UDI
- Model / Reference
- 955850 EUDAMEDFDA UDI
- Description
- CleanCart A FDA UDI
Identifiers
- Catalog Number
- 955850 FDA UDI
- Primary DI / UDI-DI
- 07332414127213 EUDAMEDFDA UDI
- Basic UDI-DI
- 7332414VA00003634 EUDAMED
- 510(k) Number
- K232467 FDA UDI
- FDA Product Code
- KDI FDA UDI
- EMDN Code
- D99 DISINFECTANTS, ANTISEPTICS, STERILISING AGENTS AND DETERGENTS FOR MEDICAL DEVICES - OTHER EUDAMED
- GMDN Term
- Sodium carbonate haemodialysis system cleaning cartridge FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5860 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Dimensions & Sizes
- Size
- Weight — 13 Gram FDA UDI
Cleancart A by Vantive Health GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7332414VA00003634 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vantive Health GmbH
- EUDAMED SRN
- CH-MF-000038981
- Authorised Representative
- Vantive S.r.l. IT-AR-000041309
Sources (2)
- EUDAMED 273ec37c-ae77-4336-8855-14e0dfbb450e 61 fields · synced Jun 18, 2026
- FDA UDI 6b850034-1213-4c51-96eb-b1945b11a391 38 fields · synced May 30, 2026