Duns Number:961027315
Device Description: Ultra Forehead Temperature
Catalog Number
14677-493
Brand Name
CARDINAL HEALTH
Version/Model Number
14677-493
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KPD
Product Code Name
STRIP, TEMPERATURE, FOREHEAD, LIQUID CRYSTAL
Public Device Record Key
0dd82dfc-17e7-45ed-ba8c-a90bd8f66a6e
Public Version Date
February 24, 2020
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
50885380113893
Quantity per Package
2
Contains DI Package
20885380113892
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |