Identity
- Trade Name
- Exergen Light Touch FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- LTX-1 Calibration Celcius FDA UDI
- Model / Reference
- LTX-1 FDA UDI
- Description
- LTX-1 Calibration Celcius FDA UDI
Identifiers
- Catalog Number
- 133820C FDA UDI
- Primary DI / UDI-DI
- 10834098000393 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
- 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
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
Yes
FDA UDI
Exergen Light Touch by Exergen Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K882949 also covers:
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 3d538a7a-e9e6-49c9-a523-b98702b8a91a 37 fields · synced Jun 9, 2026