Duns Number:089138159
Device Description: A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal A hand-held, battery-powered, electronic instrument designed for oral, under arm or rectal use to measure a patient's body temperature. The device has a flexible tip and an LCD display. It is designed to take a temperature reading in approximately 10 seconds. This is a reusable device.
Catalog Number
-
Brand Name
Premier Value
Version/Model Number
KD-2050
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
4740eef0-cdcb-4b44-b6e3-407f812b7f11
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
40840986027510
Quantity per Package
6
Contains DI Package
20840986027516
Package Discontinue Date
-
Package Status
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |