Identity
- Trade Name
- PHILIPS IntelliVue Tympanic Temperature Module FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- Tympanic Temperature Module for measuring spot-check temperature in the ear for neonates, pediatric and adult patients. The result of this measurement can be automatically adjusted to correspond to a different body reference site: Ear, Oral, Core and Rectal. The Module is compatible with IntelliVue Patient Monitors MP5SC/MP5-MP90 and MX400-MX800 and Avalon Fetal Monitors. Please check software requirements for compatibility. Package includes measurement device, holder for mounting on the table, on the wall or on the roll stand and starter pack of 96 covers. FDA UDI
- Model / Reference
- Tympanic Temperature Module FDA UDI
- Description
- Tympanic Temperature Module for measuring spot-check temperature in the ear for neonates, pediatric and adult patients. The result of this measurement can be automatically adjusted to correspond to a different body reference site: Ear, Oral, Core and Rectal. The Module is compatible with IntelliVue Patient Monitors MP5SC/MP5-MP90 and MX400-MX800 and Avalon Fetal Monitors. Please check software requirements for compatibility. Package includes measurement device, holder for mounting on the table, on the wall or on the roll stand and starter pack of 96 covers. FDA UDI
Identifiers
- Catalog Number
- 866149 FDA UDI
- Primary DI / UDI-DI
- 00884838038615 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, ear 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
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 Tympanic Temperature Module by Philips Medizin Systeme Böblingen GmbH — Class II — FDA UDI — listed in FDA GUDID
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 edfd6491-7781-4f71-9ee1-74a30fe02624 36 fields · synced May 30, 2026