Identity
- Trade Name
- QUADROX-i FDA UDI
- Generic Name
- Cardiotomy reservoir FDA UDI
- Model / Reference
- Adult, reservoir, filter FDA UDI
Identifiers
- Catalog Number
- 70106.7950 FDA UDI
- Primary DI / UDI-DI
- 04037692009994 FDA UDI
- 510(k) Number
- K132166 FDA UDI
- FDA Product Code
- JOD FDA UDIDTP FDA UDIDTN FDA UDI
- GMDN Term
- Cardiotomy reservoir FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4270 FDA UDI870.4230 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 |
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Manufacturer
- Manufacturer
- Maquet Cardiopulmonary AG
Sources (1)
- FDA UDI b5f1e04a-9da0-4720-bbe9-0f5a93b50411 36 fields · synced May 30, 2026