Duns Number:787328772
Device Description: Dual Scale Digital Thermometer, 60 second read, for oral, rectal, or axillary use
Catalog Number
16809
Brand Name
Dual Scale Digital Thermometer
Version/Model Number
16809
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)
Yes
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
K940686,K940686
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
e95ee900-aa8c-4f7c-b0c3-b8f4c7bcd103
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 18, 2017
Package DI Number
10612606001502
Quantity per Package
24
Contains DI Package
00612606001505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |