Duns Number:122612547
Device Description: Braun ThermoScan 7 Thermometer (in ship in own container packaging)
Catalog Number
-
Brand Name
Braun
Version/Model Number
IRT6520BAM
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
K103800,K103800
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
6e72a116-e5e7-4fec-81bd-086bf45e16d3
Public Version Date
May 27, 2020
Public Version Number
2
DI Record Publish Date
September 28, 2018
Package DI Number
10328785001935
Quantity per Package
1
Contains DI Package
00328785001938
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 |