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System M

FDA UDI

Class II (US FDA UDI)

by Spectrum Medical Limited

Identity

Trade Name
System M FDA UDI
Generic Name
Extracorporeal blood gas/pH monitor FDA UDI
Device Name
Exhaust Module for use with Gas Modules as part of Gas Management System FDA UDI
Model / Reference
Exhaust Module FDA UDI
Description
Exhaust Module for use with Gas Modules as part of Gas Management System FDA UDI

Identifiers

Catalog Number
3003-031-005 FDA UDI
Primary DI / UDI-DI
05060434420206 FDA UDI
510(k) Number
K110957 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

No

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

Category: Extracorporeal blood gas/pH monitor

System M 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 c6bb96cc-7363-43a9-b857-d68ad1b953b6 36 fields · synced May 30, 2026