MOBI - MOBI Air Non-Contact Digital Thermometer - MOBI TECHNOLOGIES, INC.

Duns Number:137468570

Device Description: MOBI Air Non-Contact Digital Thermometer

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More Product Details

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

Product Characteristics

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 Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

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

Additional Identifiers

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

"MOBI TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6