Catalog Number

-

Brand Name

MOBI

Version/Model Number

70119

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

K100488,K100488,K100488

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d1b1ebe5-81e6-45a9-b6b3-75db76e48613

Public Version Date

December 31, 2020

Public Version Number

5

DI Record Publish Date

August 30, 2017

Package DI Number

10891040701197

Quantity per Package

3

Contains DI Package

00891040701190

Package Discontinue Date

December 31, 2020

Package Status

Not in Commercial Distribution

Package Type

Cardboard