Identity
- Trade Name
- System M ® FDA UDI
- Generic Name
- Extracorporeal blood gas/pH monitor FDA UDI
- Device Name
- High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-005) FDA UDI
- Model / Reference
- Gas Management System FDA UDI
- Description
- High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-005) FDA UDI
Identifiers
- Catalog Number
- 3003-030-HB9 FDA UDI
- Primary DI / UDI-DI
- 05060434420169 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
- 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
Yes
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
System M ® by Spectrum Medical Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K110957 also covers:
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 3601a653-1fb8-4ddb-b8ae-fe8347992b3a 37 fields · synced Jun 6, 2026