Duns Number:198227881
Device Description: Braun Thermoscan Pro 6000 Ear Thermometer Charging Station, North America (#104894 Recharg Braun Thermoscan Pro 6000 Ear Thermometer Charging Station, North America (#104894 Rechargeable battery and #105785 Powercord included)
Catalog Number
06000-100
Brand Name
Welch Allyn, Inc.
Version/Model Number
901009
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 12, 2021
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152748
Product Code
FLL
Product Code Name
Thermometer, electronic, clinical
Public Device Record Key
b5f95742-0cbd-4f25-92bb-9dd9f3f32f64
Public Version Date
March 15, 2021
Public Version Number
2
DI Record Publish Date
March 19, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |