Duns Number:126646582
Device Description: A hand-held, battery powered, electronic instrument designed to measure a patient's body t A hand-held, battery powered, electronic instrument designed to measure a patient's body temperature from the forehead. The device has a rigid tip and an LCD display. It is designed to take a temperature reading. This is a reusable device.
Catalog Number
-
Brand Name
Polygreen
Version/Model Number
KI-8280
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
-
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
0785cc68-1727-41b6-9b42-77607783f6e3
Public Version Date
May 06, 2020
Public Version Number
1
DI Record Publish Date
April 28, 2020
Package DI Number
20809148200808
Quantity per Package
6
Contains DI Package
00809148200804
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 19 |