Catalog Number

-

Brand Name

MOBI

Version/Model Number

70100

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2019

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

K172870,K172870,K172870

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

8debcfc3-82f5-472f-8df2-e6c0330331a8

Public Version Date

July 01, 2019

Public Version Number

2

DI Record Publish Date

May 07, 2019

Package DI Number

20891040701002

Quantity per Package

4

Contains DI Package

10891040701005

Package Discontinue Date

May 06, 2019

Package Status

Not in Commercial Distribution

Package Type

Cardboard