Duns Number:830437997
Device Description: Veridian Talking Ear/Forehead Thermometer
Catalog Number
09-342
Brand Name
Veridian
Version/Model Number
09-342
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
9a09a042-2b54-4519-9ec5-9de339eb743f
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
September 23, 2019
Package DI Number
10845717009222
Quantity per Package
24
Contains DI Package
00845717009225
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 |