Identity
- Trade Name
- System M ® FDA UDI
- Generic Name
- Extracorporeal blood gas/pH monitor FDA UDI
- Device Name
- Tube ID 3/16" x Wall 1/16" (OD 5/16") FDA UDI
- Model / Reference
- Hct / SO2 Sensor FDA UDI
- Description
- Tube ID 3/16" x Wall 1/16" (OD 5/16") FDA UDI
Identifiers
- Catalog Number
- 3003-010-023 FDA UDI
- Primary DI / UDI-DI
- 05060434420084 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
- Not 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
System M ® by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 a8212ab4-7ab3-427c-8370-d4f803659c8c 36 fields · synced Jun 8, 2026