Duns Number:122612547
Device Description: Thermometer, Braun NoTouch, baby version.
Catalog Number
-
Brand Name
Braun
Version/Model Number
NTF3000B
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
0792b443-e419-4e6c-9552-14cafbb34d85
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
10328785000396
Quantity per Package
6
Contains DI Package
00328785000399
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 97 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |