Identity
- Trade Name
- QUADROX-i FDA UDI
- Generic Name
- Extracorporeal membrane oxygenator FDA UDI
- Model / Reference
- Small Adult, Filter; BIOLINE Coating FDA UDI
Identifiers
- Catalog Number
- 70106.7911 FDA UDI
- Primary DI / UDI-DI
- 04037692009970 FDA UDI
- 510(k) Number
- K150267 FDA UDI
- FDA Product Code
- DTR FDA UDIDTM FDA UDIDTZ FDA UDI
- GMDN Term
- Extracorporeal membrane oxygenator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.4240 FDA UDI870.4260 FDA UDI870.4350 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 295 Milliliter FDA UDI
QUADROX-i by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K150267 also covers:
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 4f33edd3-fe5d-45a3-a200-9a885263fff0 37 fields · synced May 30, 2026