Identity
- Trade Name
- American Red Cross FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- This thermometer is intended to measure core body temperature of infants and adults through the ear or to measure forehead temperature. It can also measure surface temperatures of objects like baby bottles. Perfect for home, office or clinical use. FDA UDI
- Model / Reference
- A201 FDA UDI
- Description
- This thermometer is intended to measure core body temperature of infants and adults through the ear or to measure forehead temperature. It can also measure surface temperatures of objects like baby bottles. Perfect for home, office or clinical use. FDA UDI
Identifiers
- Catalog Number
- AR3105 FDA UDI
- Primary DI / UDI-DI
- 84617503105013 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Infrared patient thermometer, skin
American Red Cross by Creative Concepts Manufacturing Limited — 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
- Creative Concepts Manufacturing Limited
Sources (1)
- FDA UDI db35d047-1082-4e5d-af08-35fe2d72c72b 35 fields · synced May 30, 2026