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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
SO2 SO2 Twin FDA UDI
Model / Reference
SO2 Sensor FDA UDI
Description
SO2 SO2 Twin FDA UDI

Identifiers

Catalog Number
3003-001-010 FDA UDI
Primary DI / UDI-DI
05060434420237 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

Yes

FDA UDI

Serial Number

No

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 e8ccf41d-15a1-4116-95cb-e917b90eec73 35 fields · synced Jun 7, 2026