Catalog Number

-

Brand Name

MOBI

Version/Model Number

700026

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K172795,K172795,K172795

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

fa624a42-2151-434f-9ae6-97963c300d47

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 31, 2022

Package DI Number

10891040000269

Quantity per Package

3

Contains DI Package

00891040000262

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard