Duns Number:804085293
Device Description: HARMON 60 SECOND DIGITAL THERMOMETER W/BEEPER FAHRENHEIT
Catalog Number
15-691-427
Brand Name
Face Values
Version/Model Number
15-691-427
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
00c11bf3-9717-4ef2-82db-89ef1bd886ce
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 12, 2016
Package DI Number
30767056427014
Quantity per Package
6
Contains DI Package
00767056427013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |