Identity
- Trade Name
- TCM4x Cable FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- TOSCA 500 Embla MDrive interface cable. Connecting cable to an external device (PSG). FDA UDI
- Model / Reference
- 903-341 FDA UDI
- Description
- TOSCA 500 Embla MDrive interface cable. Connecting cable to an external device (PSG). FDA UDI
Identifiers
- Catalog Number
- 903-341 FDA UDI
- Primary DI / UDI-DI
- 05700699033413 FDA UDI
- FDA Product Code
- DQA FDA UDILKD FDA UDIDPZ FDA UDI
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI868.2480 FDA UDI870.2710 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
Yes
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
No
FDA UDI
TCM4x Cable by Radiometer Basel AG — 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
- Radiometer Basel AG
Sources (1)
- FDA UDI a4407144-dae3-4896-836f-beea034acf2b 36 fields · synced May 30, 2026