Duns Number:063997360
Device Description: LDR Digital Thermometers 9 sec Display box of 9 ea
Catalog Number
5305297
Brand Name
LEADER
Version/Model Number
5305297
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 11, 2022
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
c8d49575-a0eb-4582-baa3-9616baa78877
Public Version Date
October 12, 2022
Public Version Number
3
DI Record Publish Date
April 14, 2017
Package DI Number
50096295130787
Quantity per Package
24
Contains DI Package
30096295130783
Package Discontinue Date
October 11, 2022
Package Status
Not 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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |