Duns Number:122612547
Device Description: Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package contains 20 probe covers. Not for individual sale.The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal.
Catalog Number
-
Brand Name
Braun
Version/Model Number
PC20KB
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
Yes
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
96627d72-b910-4bdb-9afe-8c266b7de182
Public Version Date
May 27, 2020
Public Version Number
3
DI Record Publish Date
August 29, 2016
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 | 97 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |