Duns Number:868703513
Device Description: A hand-held, battery-powered, electronic instrument designed to measure the temperature of A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal using infrared radiation. It has a swivel head probe and an LCD display. This is a reusable device.
Catalog Number
-
Brand Name
Best Choice
Version/Model Number
KI-8160
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
2831a246-e93d-4fd2-863b-1a61249cd718
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
40070038605162
Quantity per Package
4
Contains DI Package
20070038605168
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |