Identity
- Trade Name
- QUADROX-i FDA UDI
- Generic Name
- Cardiotomy reservoir FDA UDI
- Device Name
- QUADROX-i Small Adult HMO 51000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight FDA UDI
- Model / Reference
- Small Adult, reservoir, filter VKMO 51000-USA #SQUADR-i HMO51000+VHK710 FDA UDI
- Description
- QUADROX-i Small Adult HMO 51000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight FDA UDI
Identifiers
- Catalog Number
- 70106.7970 FDA UDI
- Primary DI / UDI-DI
- 04058863018867 FDA UDI
- FDA Product Code
- DTP FDA UDIJOD FDA UDIDTN FDA UDI
- GMDN Term
- Cardiotomy reservoir FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4230 FDA UDI870.4270 FDA UDI870.4400 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
QUADROX-i by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — 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
- Maquet Cardiopulmonary AG
Sources (1)
- FDA UDI 55f58c34-b4fe-4c8b-94b3-7525c752bc5b 36 fields · synced Jun 6, 2026