Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors FDA UDI
Generic Name: Cardiopulmonary bypass system centrifugal pump FDA UDI
Model / Reference: CP22V-VT FDA UDI

Identifiers

Primary DI / UDI-DI: 08051160300624 FDA UDI
510(k) Number: K201320 FDA UDI
FDA Product Code: KFM FDA UDI
GMDN Term: Cardiopulmonary bypass system centrifugal pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4360 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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cardiopulmonary bypass system centrifugal pump

Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID

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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: Spectrum Medical Limited

Sources (1)

FDA UDI 041e784f-ed3e-4534-b0db-51af7753b6cd 33 fields · synced May 30, 2026