DEVICE: 1byone (00858069007054)
Device Identifier (DI) Information
1byone
NT17
In Commercial Distribution
1BYONEPRODUCTS INC.
NT17
In Commercial Distribution
1BYONEPRODUCTS INC.
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
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| No | |
| No | |
| No | |
| No | |
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| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 17888 | Infrared patient thermometer, skin |
A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| FLL | Thermometer, Electronic, Clinical |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K081160 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
e2ebfcaa-26f8-48cd-9bcb-28642c940d57
December 04, 2020
4
April 12, 2018
December 04, 2020
4
April 12, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20858069007058 | 40 | 10858069007051 | In Commercial Distribution | Outer carton | |
| 10858069007051 | 1 | 00858069007054 | In Commercial Distribution | Gift box |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined