Identity
- Trade Name
- 1byone FDA UDI
- Generic Name
- Infrared patient thermometer, skin FDA UDI
- Device Name
- TOUCH-FREE INFRARED THERMOMETER - 4 in 1 Function : Forehead/Object/Night Mode/Back Light - Measuring Range : 34~43℃ - Operation Distance：1 inch (2.5cm) - 30-memory Recall - Fever Indication - ℃ / ℉ Switch-able Function - Battery: 2 “AAA” batteries FDA UDI
- Model / Reference
- NT17 FDA UDI
- Description
- TOUCH-FREE INFRARED THERMOMETER - 4 in 1 Function : Forehead/Object/Night Mode/Back Light - Measuring Range : 34~43℃ - Operation Distance：1 inch (2.5cm) - 30-memory Recall - Fever Indication - ℃ / ℉ Switch-able Function - Battery: 2 “AAA” batteries FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00858069007054 FDA UDI
- 510(k) Number
- K081160 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Infrared patient thermometer, skin
1byone by 1byoneproducts Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081160 also covers:
- Adtemp™ — American Diagnostic Corporation
- Diagnostix. — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
- Diagnostix™ — American Diagnostic Corporation
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
- 1byoneproducts Inc.
Sources (1)
- FDA UDI e2ebfcaa-26f8-48cd-9bcb-28642c940d57 34 fields · synced May 30, 2026