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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 Workstation 12" FDA UDI
Model / Reference
QWS12 FDA UDI
Description
Quantum Workstation 12" FDA UDI

Identifiers

Catalog Number
51-000031-00 FDA UDI
Primary DI / UDI-DI
05060434420718 FDA UDI
510(k) Number
K181923 FDA UDI
FDA Product Code
DRY FDA UDI
GMDN Term
Extracorporeal blood gas/pH monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.4330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe 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

Similar devices

Also classified as Extracorporeal blood gas/pH monitor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spectrum Medical Limited

Sources (1)

  • FDA UDI 5e0793a0-9b07-432e-b848-f2fe9e8418b7 37 fields · synced May 30, 2026