Duns Number:006999528
Device Description: KROGER 9 SECOND FLEXIBLE TIP DIGITAL THERMOMETER DUAL SCALE
Catalog Number
112-757-000
Brand Name
Kroger
Version/Model Number
112-757-000
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
K041516,K041516,K041516
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
0a08a366-99ed-480b-88ca-3e4db2cb6000
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 18, 2016
Package DI Number
10011110381030
Quantity per Package
24
Contains DI Package
30011110381034
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |