Duns Number:108999095
Device Description: ADTEMP 429 Non-Contact Thermometer, 1 second
Catalog Number
429
Brand Name
Adtemp™
Version/Model Number
429
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
K081160,K081160,K081160
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c25dbeaf-be7a-4227-beb1-6c13b683969f
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
00634782584863
Quantity per Package
8
Contains DI Package
00634782884864
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |