Catalog Number

-

Brand Name

MOBI

Version/Model Number

70125

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 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

K113761,K113761,K113761

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

cb189849-3e65-4321-a9c4-ce94d4826d4c

Public Version Date

December 31, 2020

Public Version Number

4

DI Record Publish Date

October 19, 2017

Package DI Number

10891040701258

Quantity per Package

3

Contains DI Package

00891040701251

Package Discontinue Date

December 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Cardboard