Identity
- Trade Name
- ARC InstaTemp Infrared Thermometer FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- InstaTemp Digital Non-Touch Infrared Thermometer is intended to be used to measure temperature in infants and adults. The InstaTemp can be used in the home or in the clinical setting. FDA UDI
- Model / Reference
- 600 FDA UDI
- Description
- InstaTemp Digital Non-Touch Infrared Thermometer is intended to be used to measure temperature in infants and adults. The InstaTemp can be used in the home or in the clinical setting. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853524006009 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, skin
ARC InstaTemp Infrared Thermometer by Arc Devices Usa Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II
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
- Arc Devices Usa Inc
Sources (1)
- FDA UDI 8e874108-05a6-450a-a047-f82deae26cbc 33 fields · synced May 30, 2026