Duns Number:137468570
Device Description: Non-Contact Thermometer
Catalog Number
-
Brand Name
MOBI
Version/Model Number
70113
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 31, 2025
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
c1cb3dd2-1714-4670-be8c-5c8467a274fc
Public Version Date
December 04, 2020
Public Version Number
2
DI Record Publish Date
April 08, 2020
Package DI Number
20891040701132
Quantity per Package
40
Contains DI Package
00891040701138
Package Discontinue Date
October 31, 2023
Package Status
In Commercial Distribution
Package Type
Cardboard
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |