Identity
- Trade Name
- PHILIPS Transcutaneous pO2/pCO2 Parameter Module FDA UDI
- Generic Name
- Patient monitoring system module, blood gas, transcutaneous FDA UDI
- Model / Reference
- 862283 FDA UDI
Identifiers
- Catalog Number
- 862283 FDA UDI
- Primary DI / UDI-DI
- 00884838021006 FDA UDI
- FDA Product Code
- KLK FDA UDI
- GMDN Term
- Patient monitoring system module, blood gas, transcutaneous FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2500 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, blood gas, transcutaneous
PHILIPS Transcutaneous pO2/pCO2 Parameter Module by Philips Medizin Systeme Böblingen GmbH — Class II — FDA UDI — listed in FDA GUDID
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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
- Philips Medizin Systeme Böblingen GmbH
Sources (1)
- FDA UDI 32daf90a-9f0e-4e2d-9ae5-cbd06392e327 34 fields · synced Jun 1, 2026