Duns Number:529391821
Catalog Number
-
Brand Name
BERRCOM
Version/Model Number
DT008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 14, 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"
Yes
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
2b417a05-5ffa-4126-8f1f-bee6854f2178
Public Version Date
November 29, 2021
Public Version Number
2
DI Record Publish Date
October 14, 2021
Package DI Number
66947656113646
Quantity per Package
200
Contains DI Package
06947656113644
Package Discontinue Date
October 14, 2021
Package Status
Not in Commercial Distribution
Package Type
Cartoon
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2 |
2 | A medical device with a moderate to high risk that requires special controls. | 66 |