Duns Number:845019202
Device Description: TOUCH-FREE INFRARED THERMOMETER- 4 in 1 Function : Forehead/Object/Night Mode/Back Light- 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
Catalog Number
-
Brand Name
1byone
Version/Model Number
NT17
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K081160,K081160,K081160
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
e2ebfcaa-26f8-48cd-9bcb-28642c940d57
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
April 12, 2018
Package DI Number
20858069007058
Quantity per Package
40
Contains DI Package
10858069007051
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Outer carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |