Duns Number:830437997
Device Description: 60-Second Digital Thermometer
Catalog Number
-
Brand Name
Veridian
Version/Model Number
08-352
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
K041516
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
43225ca0-d66a-4479-a2bf-10a06e95eb29
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
March 28, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |