Duns Number:108999095
Device Description: ADTEMP 432 Non-Contact Thermometer, Mini, 1 second (cable & lanyard included)
Catalog Number
432
Brand Name
Adtemp™
Version/Model Number
432
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
K102947,K102947,K102947
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
6a37a63d-8a18-41a8-b0c0-850692108df7
Public Version Date
December 04, 2020
Public Version Number
3
DI Record Publish Date
January 02, 2020
Package DI Number
00634782597443
Quantity per Package
8
Contains DI Package
00634782897444
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 |