Duns Number:122612547
Device Description: Thermometer, Braun Infrared ThermoScan Ear w/21 filters - for intermittent measurement of Thermometer, Braun Infrared ThermoScan Ear w/21 filters - for intermittent measurement of temperature for patients of all ages, this thermometer is used with lens filters.
Catalog Number
IRT6020US
Brand Name
Braun
Version/Model Number
IRT6020US
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
f6177d9c-5736-4d7a-9cb9-a6913d19696a
Public Version Date
May 27, 2020
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
10328785000099
Quantity per Package
6
Contains DI Package
00328785000092
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 |