Catalog Number

-

Brand Name

MOBI

Version/Model Number

70111

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2025

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

K101387,K101387,K101387

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9ebb7ce8-2fc1-4351-829d-abeec3f9712d

Public Version Date

May 15, 2020

Public Version Number

1

DI Record Publish Date

May 07, 2020

Package DI Number

10891040701111

Quantity per Package

12

Contains DI Package

00891040701114

Package Discontinue Date

December 31, 2025

Package Status

In Commercial Distribution

Package Type

Cardboard