Duns Number:079758824
Device Description: InstaTemp Digital Non-Touch Thermometer is intended to be used to measure temperature in i InstaTemp Digital Non-Touch 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
Catalog Number
-
Brand Name
ARC InstaTemp Infrared Thermometer
Version/Model Number
601
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
f3780cd3-08f0-4224-839d-05148267103c
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
March 30, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |