Duns Number:787828537
Device Description: High accuracy and fast response, easy to read digital display. Peak-hold and auto shut-of High accuracy and fast response, easy to read digital display. Peak-hold and auto shut-off functions. Break-resistant and child-safe probe. Low battery indication.
Catalog Number
-
Brand Name
ViaMed
Version/Model Number
13110
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
c706fed9-2792-47d4-9d11-935fac22da5e
Public Version Date
October 25, 2021
Public Version Number
1
DI Record Publish Date
October 15, 2021
Package DI Number
00811382011726
Quantity per Package
200
Contains DI Package
00811382015601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |