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QUADROX-i

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name
QUADROX-i FDA UDI
Generic Name
Extracorporeal membrane oxygenator FDA UDI
Model / Reference
Small Adult FDA UDI

Identifiers

Catalog Number
70105.5281 FDA UDI
Primary DI / UDI-DI
04037691843346 FDA UDI
510(k) Number
K132829 FDA UDI
FDA Product Code
DTR FDA UDI
DTZ FDA UDI
GMDN Term
Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4240 FDA UDI
870.4350 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

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

Cleared under the same submission

K132829 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (1)

  • FDA UDI bcd7c631-ce3b-44f4-9c9b-178dee15e295 36 fields · synced Jun 8, 2026