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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 heating/cooling unit FDA UDI
Device Name
Quantum Heater Cooler FDA UDI
Model / Reference
QHC1 FDA UDI
Description
Quantum Heater Cooler FDA UDI

Identifiers

Catalog Number
51-000058-00 FDA UDI
Primary DI / UDI-DI
05060434420961 FDA UDI
FDA Product Code
DWC FDA UDI
GMDN Term
Cardiopulmonary bypass system heating/cooling unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4250 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
MRI Safety
MR Unsafe FDA UDI

Category: Cardiopulmonary bypass system heating/cooling 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 heating/cooling unit.

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 5ff3dbcb-9799-4e74-9eb5-f8215579edf5 36 fields · synced May 31, 2026