Quantum ®

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name: Quantum ® FDA UDI
Generic Name: Extracorporeal blood gas/pH monitor FDA UDI
Device Name: Quantum Pump Frame 1 - Blackpool FDA UDI
Model / Reference: QPF1 FDA UDI
Description: Quantum Pump Frame 1 - Blackpool FDA UDI

Identifiers

Catalog Number: 51-000024-00 FDA UDI
Primary DI / UDI-DI: 05060434420749 FDA UDI
510(k) Number: K173834 FDA UDI
FDA Product Code: DTQ FDA UDI
GMDN Term: Extracorporeal blood gas/pH monitor 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Extracorporeal blood gas/pH monitor

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

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CDI® Blood Parameter Monitoring System 550 — Terumo Cardiovascular Systems Corporation · Class II
BioTrend® — MEDTRONIC, INC. · Class II
BioTrend® — MEDTRONIC, INC. · Class II
BioTrend® — MEDTRONIC, INC. · 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 f872f92d-ee76-44a7-9e67-9db01db3ff91 37 fields · synced May 30, 2026