Duns Number:680004711
Device Description: This thermometer is intended to measure body temperature using its sensor tip. It can be u This thermometer is intended to measure body temperature using its sensor tip. It can be used under the tongue (oral), in the armpit (axillary), or in the rectum (rectal) to take readings. Perfect for home or clinical use.
Catalog Number
R3106
Brand Name
American Red Cross
Version/Model Number
KFT-05
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
0456e94f-f67c-411d-ac03-63a4a2f21e0c
Public Version Date
December 22, 2021
Public Version Number
1
DI Record Publish Date
December 11, 2021
Package DI Number
84617503106126
Quantity per Package
12
Contains DI Package
84617503106010
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 |