Duns Number:177667227
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 rigid tip and an LCD display. It is designed to take a temperature reading in approximately 60 seconds. This is a reusable device.
Catalog Number
KD-1540.SMK
Brand Name
Sunmark
Version/Model Number
KD-118
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
71e83418-6c55-4fd3-9186-f0d0d83a37fc
Public Version Date
June 11, 2020
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
40038703001183
Quantity per Package
8
Contains DI Package
20038703001189
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. | 25 |