Duns Number:007914906
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 inner ear. The device has an infrared probe and an LCD display. It is designed to take a temperature reading in approximately 5 seconds. This is a reusable device.
Catalog Number
-
Brand Name
Good Neighbor Pharmacy
Version/Model Number
KI-8170
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
0f14120a-2afe-4a39-859d-6cf6f6001fdc
Public Version Date
August 08, 2022
Public Version Number
3
DI Record Publish Date
September 20, 2016
Package DI Number
10087701400329
Quantity per Package
4
Contains DI Package
20087701400326
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. | 13 |