Identity
- Trade Name
- FiberTEMP Fiber Optic Surface Temperature Sensor FDA UDI
- Generic Name
- Continuous electronic patient thermometer, battery-powered FDA UDI
- Model / Reference
- 989803152801 FDA UDI
Identifiers
- Catalog Number
- 989803152801 FDA UDI
- Primary DI / UDI-DI
- 00884838004979 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Continuous electronic patient thermometer, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
FiberTEMP Fiber Optic Surface Temperature Sensor by Philips DS North America LLC — 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 DS North America LLC
Sources (1)
- FDA UDI 11865d23-d9b1-450b-8c42-b0ac0707abfe 35 fields · synced Jun 8, 2026