Duns Number:830437997
Device Description: 2-Second Flexible Tip Digital Thermometer
Catalog Number
08-363
Brand Name
Veridian
Version/Model Number
08-363
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K983887,K983887,K983887
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
7cd22a5a-2d94-43fd-8a52-a5f5431915cb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10845717006634
Quantity per Package
36
Contains DI Package
30845717006638
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |