Duns Number:680004711
Device Description: Intended UseThis thermometer is intended to measure core body temperature of infants and a Intended UseThis thermometer is intended to measure core body temperature of infants and adults through the ear. It can also measure surface temperatures of objects like baby bottles.Advantages of Using an Ear ThermometerThe eardrum shares blood supply with the hypothalamus which makes for a more accurate reading than other body parts.
Catalog Number
AR3103
Brand Name
American Red Cross
Version/Model Number
DET-103
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
cc336fae-2104-4eed-95df-c7bd4b131bfe
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 2021
Package DI Number
84617503103125
Quantity per Package
12
Contains DI Package
84617503103019
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 |