Duns Number:062312574
Device Description: A hand-held battery-powered electronic instrument designed to measure a patient's body tem A hand-held battery-powered electronic instrument designed to measure a patient's body temperature using infrared waves. The device has a infrared probe and an LCD display. It is designed to take a temperature reading in approximately 1 second. This is a reusable device.
Catalog Number
-
Brand Name
CVS Health
Version/Model Number
KI-8360HD.CVS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 22, 2021
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)
-
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
1f83dc6f-6e5c-4c8a-ac73-d6b5548dc9a6
Public Version Date
March 23, 2021
Public Version Number
2
DI Record Publish Date
December 10, 2020
Package DI Number
40050428635856
Quantity per Package
48
Contains DI Package
00504286358584
Package Discontinue Date
March 22, 2021
Package Status
Not 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 | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139 |
| U | Unclassified | 23 |