Duns Number:122612547
Device Description: Braun ThermoScan PRO6000 Ear Thermometer - intended for intermittent measurement of temper Braun ThermoScan PRO6000 Ear Thermometer - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" as indicated below.
Catalog Number
-
Brand Name
Braun
Version/Model Number
PRO6000BPV2
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
203a3923-38a3-4372-b340-d0c8af36a931
Public Version Date
May 27, 2020
Public Version Number
3
DI Record Publish Date
August 29, 2016
Package DI Number
10328785000600
Quantity per Package
25
Contains DI Package
00328785000603
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 |