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: Tube ID 3/8" x Wall 3/32" (OD 9/16") FDA UDI
Model / Reference: Hct / SO2 Sensor FDA UDI
Description: Tube ID 3/8" x Wall 3/32" (OD 9/16") FDA UDI

Identifiers

Catalog Number: 3003-010-020 FDA UDI
Primary DI / UDI-DI: 05060434420053 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

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

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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 4c1d4299-750a-48b2-9d42-48f8dc53b38f 35 fields · synced May 31, 2026