Identity
- Trade Name
- Oto Temp Probe Covers FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- Oto Temp Probe Covers Disposable Optical Film for Use on Ototemp Infrared Thermometers FDA UDI
- Model / Reference
- PCT-2500 Disposable Wraps FDA UDI
- Description
- Oto Temp Probe Covers Disposable Optical Film for Use on Ototemp Infrared Thermometers FDA UDI
Identifiers
- Catalog Number
- 128600, 128800, 128910 FDA UDI
- Primary DI / UDI-DI
- 10834098000324 FDA UDI
- 510(k) Number
- K882949 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
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
Category: Infrared patient thermometer, ear
Oto Temp Probe Covers by Exergen Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Exergen Corporation
Sources (1)
- FDA UDI 7afe1eee-bda6-4979-a5b8-58a9482eefde 36 fields · synced Jun 9, 2026