Duns Number:108999095
Device Description: Dual Scale Digital Thermometer,Bulk, KM PL
Catalog Number
413EKM-00
Brand Name
Kerma
Version/Model Number
413EKM-00
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"
Yes
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
81b96694-624a-43f5-9cb3-c4357d938df0
Public Version Date
June 07, 2018
Public Version Number
3
DI Record Publish Date
February 10, 2018
Package DI Number
00634782562861
Quantity per Package
6
Contains DI Package
00634782862862
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Master Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2395 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1769 |