Quantum

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 52-000095-00

by Spectrum Medical Limited

Identity

Trade Name: Quantum FDA UDI
Generic Name: Cardiopulmonary bypass system gas control unit FDA UDI
Device Name: Gas Sample Line 0.2 m EUDAMED
Gas Sample Line Kit FDA UDI
Model / Reference: 52-000095-00 EUDAMEDFDA UDI
Description: Gas Sample Line Kit FDA UDI

Identifiers

Catalog Number: 52-000095-00 FDA UDI
Primary DI / UDI-DI: 05060434423818 EUDAMEDFDA UDI
Basic UDI-DI: 506043442GSLDA EUDAMED
510(k) Number: K202733 FDA UDI
FDA Product Code: DTX FDA UDI
EMDN Code: Z12050280 EXTRA-CORPOREAL CIRCULATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term: Cardiopulmonary bypass system gas control unit FDA UDI

Classification

Device Class: Class I EUDAMED
Class II FDA UDI
Regulation Number: 870.4300 FDA UDI
Market of Registration: Belgium EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Cardiopulmonary bypass system gas control unit

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

Similar devices

Also classified as Cardiopulmonary bypass system gas control unit.

Terumo® Advanced Perfusion System 1 — Terumo Cardiovascular Systems Corporation · Class II
Sarns™ Modular Perfusion System 8000 — Terumo Cardiovascular Systems Corporation · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II
Quantum — SPECTRUM MEDICAL LIMITED · Class II

Cleared under the same submission

K202733 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Spectrum Medical Limited

Sources (2)

FDA UDI ee1efe8a-5ac0-4f03-90e3-d7441f5f4610 37 fields · synced Jun 20, 2026
EUDAMED 5270bccd-b3d5-4340-b1a9-d7cc0d16dbd8 61 fields · synced Jun 20, 2026