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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
Cardiotomy reservoir FDA UDI
Device Name
QUADROX-i Adult HMO 70000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight FDA UDI
Model / Reference
Adult Oxygenator + reservoir VKMO 70000-USA #SQUADR-i HMO70000+VHK710 FDA UDI
Description
QUADROX-i Adult HMO 70000 + VHK 71000 Oxygenator with venous hardshell cardiotomy reservoir, vacuum-tight FDA UDI

Identifiers

Catalog Number
70106.7945 FDA UDI
Primary DI / UDI-DI
04058863007403 FDA UDI
FDA Product Code
DTN FDA UDI
JOD FDA UDI
DTP FDA UDI
GMDN Term
Cardiotomy reservoir FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4400 FDA UDI
870.4270 FDA UDI
870.4230 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

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Manufacturer

Manufacturer
Maquet Cardiopulmonary AG

Sources (1)

  • FDA UDI bc2e9961-8935-4ae2-b02a-0f7255b0bb11 36 fields · synced Jun 6, 2026