Identity
- Trade Name
- TekCare Touch Free Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, ear FDA UDI
- Device Name
- The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can be used upon people of all ages. FDA UDI
- Model / Reference
- NT11 FDA UDI
- Description
- The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic environment, and can be used upon people of all ages. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04710953421291 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
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, ear
TekCare Touch Free Infrared Thermometer by Avita Corporation — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Avita Corporation
Sources (2)
- FDA UDI 44b5fe1e-98d9-4b8a-8b2c-021a1851b681 34 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 28, 2026