Duns Number:076059836
Device Description: Good SenseTemple Touch Mini Thermometer
Catalog Number
69-330
Brand Name
Good Sense
Version/Model Number
69-330
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
K032362,K032362,K032362
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
228e428a-8290-4a26-8de0-3ceb538e3a7c
Public Version Date
December 04, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10846036007340
Quantity per Package
36
Contains DI Package
30846036007344
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 14 |