Duns Number:680004711
Device Description: Intended UseThis infrared thermometer is intended to measure the body temperature of infan Intended UseThis infrared thermometer is intended to measure the body temperature of infants and adults without contact. It can also be used to measure surface temperatures of objects such as baby bottles, bath water, pool water, vents and more. Perfect for home, office or clinical use.
Catalog Number
AR3102
Brand Name
American Red Cross
Version/Model Number
PC868
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"
Yes
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
2171c7cc-5b8b-4ea8-ae3d-44b8f20f1114
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 2021
Package DI Number
84617503102128
Quantity per Package
12
Contains DI Package
84617503102012
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 |