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Quantum

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name
Quantum FDA UDI
Generic Name
Cardiopulmonary bypass system gas control unit FDA UDI
Device Name
Quantum Ventilation Module - DISS (Hook Mount) FDA UDI
Model / Reference
QVM2-D-HM FDA UDI
Description
Quantum Ventilation Module - DISS (Hook Mount) FDA UDI

Identifiers

Catalog Number
51-000082-00 FDA UDI
Primary DI / UDI-DI
05060434422071 FDA UDI
510(k) Number
K202733 FDA UDI
FDA Product Code
DTX FDA UDI
GMDN Term
Cardiopulmonary bypass system gas control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass system gas control unit

Quantum by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary bypass system gas control unit.

Cleared under the same submission

K202733 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Medical Limited

Sources (1)

  • FDA UDI 6e1d7965-6ce3-4744-9016-f3c89f314037 37 fields · synced Jun 6, 2026