Duns Number:183280973
Device Description: Infrared Ear/Forehead Thermometer
Catalog Number
-
Brand Name
HOMEDICS
Version/Model Number
TIE-300-BK
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
K182597,K182597
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
3bf4f8ec-6e2c-4319-9614-55c13b83fd0d
Public Version Date
February 08, 2022
Public Version Number
1
DI Record Publish Date
January 31, 2022
Package DI Number
10031262101355
Quantity per Package
6
Contains DI Package
00031262101358
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 23 |
2 | A medical device with a moderate to high risk that requires special controls. | 44 |