Quantum Perfusion Blood Oxygenator VT75-E2

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name: Quantum Perfusion Blood Oxygenator VT75-E2 FDA UDI
Generic Name: Extracorporeal membrane oxygenator FDA UDI
Model / Reference: VT75-E2 FDA UDI

Identifiers

Primary DI / UDI-DI: 18051160301871 FDA UDI
510(k) Number: K231982 FDA UDI
FDA Product Code: DTZ FDA UDI
GMDN Term: Extracorporeal membrane oxygenator FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.4350 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

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Extracorporeal membrane oxygenator

Quantum Perfusion Blood Oxygenator VT75-E2 by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems Corporation · Class II

Cleared under the same submission

K231982 also covers:

Quantum Perfusion Blood Oxygenator VT75-E1 — SPECTRUM MEDICAL LIMITED

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 f7daefe1-7b14-41f6-969b-fc7f9d605ea9 33 fields · synced May 30, 2026