Duns Number:137468570
Device Description: MOBI Air Non-Contact Digital Thermometer
Catalog Number
-
Brand Name
MOBI
Version/Model Number
70118
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2020
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
362ad636-12de-44ec-b368-93307e007b12
Public Version Date
December 04, 2020
Public Version Number
5
DI Record Publish Date
September 28, 2016
Package DI Number
20891040701187
Quantity per Package
4
Contains DI Package
10891040701180
Package Discontinue Date
January 01, 2020
Package Status
Not 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 |