Duns Number:421343701
Device Description: This product is suitable for measuring temperature of the human ear.
Catalog Number
-
Brand Name
Mothermed
Version/Model Number
IR102
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
K113761,K113761
Product Code
FLL
Product Code Name
Thermometer, Electronic, Clinical
Public Device Record Key
fd1c91dd-76ae-4b02-81e4-fc353588bbb3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 25, 2016
Package DI Number
10818218021024
Quantity per Package
40
Contains DI Package
00818218021027
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |