QUADROX-iD

FDA UDI

Class II (US FDA UDI)

by Maquet Cardiopulmonary AG

Identity

Trade Name: QUADROX-iD FDA UDI
Generic Name: Extracorporeal membrane oxygenator FDA UDI
Device Name: QUADROX-iD Adult Diffusion Membrane Oxygenator, without Filter, NON-COATED, with a screw connector. FDA UDI
Model / Reference: QUADROX-iD Adult, SOFTLINE Coating, without Filter FDA UDI
Description: QUADROX-iD Adult Diffusion Membrane Oxygenator, without Filter, NON-COATED, with a screw connector. FDA UDI

Identifiers

Catalog Number: 70106.7840 FDA UDI
Primary DI / UDI-DI: 04058863019000 FDA UDI
510(k) Number: K150267 FDA UDI
FDA Product Code: DTZ FDA UDI
DTM FDA UDI
DTR FDA UDI
GMDN Term: Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4350 FDA UDI
870.4260 FDA UDI
870.4240 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Total Volume — 215 Milliliter FDA UDI

Category: Extracorporeal membrane oxygenator

QUADROX-iD by Maquet Cardiopulmonary AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal membrane oxygenator.

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Capiox® RX Hollow Fiber Oxygenator with Hardshell Reservoir — Terumo Cardiovascular Systems Corporation · Class II
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Affinity Fusion® — MEDTRONIC, INC. · Class II
MC3 Nautilus ECMO Oxygenator — MICHIGAN CRITICAL CARE CONSULTANTS, INC. · Class II
CAPIOX — Terumo Corp. · Class II
CAPIOX®RX — Terumo Corp. · Class II
Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II

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 b822026b-06f3-44ab-a797-f9a15e07b437 37 fields · synced Jun 6, 2026