Identity
- Trade Name
- PHILIPS IntelliVue TcG10 FDA UDI
- Generic Name
- Transcutaneous blood gas monitoring system FDA UDI
- Device Name
- IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement FDA UDI
- Model / Reference
- IntelliVue TcG10 FDA UDI
- Description
- IntelliVue TcG10 Gas Modul for external transcutaneous O2 and CO2 measurement FDA UDI
Identifiers
- Catalog Number
- 865298 FDA UDI
- Primary DI / UDI-DI
- 00884838020764 FDA UDI
- FDA Product Code
- LKD FDA UDI
- GMDN Term
- Transcutaneous blood gas monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2480 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
PHILIPS IntelliVue TcG10 by Philips Medizin Systeme Böblingen GmbH — 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
- Philips Medizin Systeme Böblingen GmbH
Sources (1)
- FDA UDI f581ae5a-2d85-4b0d-9c9b-a6b218c68c0a 37 fields · synced Jun 1, 2026