Catalog Number

-

Brand Name

MOBI

Version/Model Number

70120

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 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

K100488,K100488,K100488

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2a090859-dc78-4ca9-8ab9-31486d9e74a4

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

September 28, 2016

Package DI Number

20891040701200

Quantity per Package

4

Contains DI Package

10891040701203

Package Discontinue Date

January 01, 2020

Package Status

Not in Commercial Distribution

Package Type

Cardboard