Duns Number:062312574
Device Description: A hand-held battery-powered, electronic instrument designed to measure a patient's body te A hand-held battery-powered, electronic instrument designed to measure a patient's body temperature from the temporal artery. The device has a rigid tip and an LCD display. It is designed to take a temperature reading in approximately 6 seconds. This is a reuseable device.
Catalog Number
-
Brand Name
CVS
Version/Model Number
KD-2206J.CVS
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
4e961a54-91f5-423e-b0cb-da7271361ae9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2017
Package DI Number
40050428586011
Quantity per Package
12
Contains DI Package
00050428586013
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |