Quantum

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name: Quantum FDA UDI
Generic Name: Cardiopulmonary bypass system roller pump FDA UDI
Device Name: Quantum Roller Pump - 6 inch FDA UDI
Model / Reference: QRP6 FDA UDI
Description: Quantum Roller Pump - 6 inch FDA UDI

Identifiers

Catalog Number: 51-000013-00 FDA UDI
Primary DI / UDI-DI: 05060434420787 FDA UDI
510(k) Number: K173834 FDA UDI
FDA Product Code: DTQ FDA UDI
GMDN Term: Cardiopulmonary bypass system roller pump FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiopulmonary bypass system roller pump

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 roller pump.

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Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II

Cleared under the same submission

K173834 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: Spectrum Medical Limited

Sources (1)

FDA UDI b4edea9c-3112-4fb2-8340-5d6f7261e3e0 37 fields · synced May 30, 2026