Duns Number:680004711
Device Description: Non-Contact Infrared Thermometer - Quick and Easy Body, Surface and Room Temperature Readi Non-Contact Infrared Thermometer - Quick and Easy Body, Surface and Room Temperature ReadingsSafe, non-contact thermometer for quick 1 second temperature results in Fahrenheit or Celsius. Multiple operation modes perfect for reading body, room, or surface temperatures with the press of a button. Body mode backlit display illuminates green, yellow or red to clearly indicate normal and elevated temperatures
Catalog Number
AR3100
Brand Name
American Red Cross
Version/Model Number
JXB-178
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
9f5280f4-9040-4fd1-9029-a0a0f4ffe2d6
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 23, 2021
Package DI Number
84617503100124
Quantity per Package
12
Contains DI Package
84617503100018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |