Duns Number:680004711
Device Description: 2 in 1 Infrared Thermometer - For Ear, Forehead and ObjectsFAST, SAFE, ACCURATE RESULTSSaf 2 in 1 Infrared Thermometer - For Ear, Forehead and ObjectsFAST, SAFE, ACCURATE RESULTSSafe, non-contact 2 in 1 thermometer for quick 1 second temperature results in Fahrenheit or Celsius. Multiple operation modes perfect for reading body temperatures at the forehead or ear and objects with the press of a button. Back-lit display illuminates green, orange or red to clearly indicate normal and low or elevated temperatures.
Catalog Number
AR3104
Brand Name
American Red Cross
Version/Model Number
PG-IRT1603
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
a92b89dc-ce16-4dfd-9afc-99f1083cf5b4
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 23, 2021
Package DI Number
84617503104122
Quantity per Package
12
Contains DI Package
84617503104016
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |