Identity
- Trade Name
- Truer Medical, Inc. FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Truer Medical, Inc. Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps. FDA UDI
- Model / Reference
- SSP 400 FDA UDI
- Description
- The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Truer Medical, Inc. Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps. FDA UDI
Identifiers
- Catalog Number
- SSP 400 FDA UDI
- Primary DI / UDI-DI
- 00859290006137 FDA UDI
- 510(k) Number
- K101244 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Infrared patient thermometer, skin 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
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
Yes
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Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skin
Truer Medical, Inc. by Truer Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Truer Medical, Inc.
Sources (1)
- FDA UDI e0d3c110-8e35-421f-9f93-75a7412dd03d 36 fields · synced May 31, 2026