Duns Number:108999095
Device Description: ADTEMP Ultra Dig Thermometer,2 sec, Flex tip, Lrg Disp
Catalog Number
417
Brand Name
Adtemp™
Version/Model Number
417
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
K983887,K983887,K983887
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
a77baae9-7794-46bc-9302-728e8ebb6633
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
00634782584412
Quantity per Package
4
Contains DI Package
00634782884413
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 |