Catalog Number

-

Brand Name

MOBI

Version/Model Number

70117

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

K161735,K161735,K161735

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d115b1cd-e5de-4beb-b697-680fca25db53

Public Version Date

April 05, 2022

Public Version Number

1

DI Record Publish Date

March 28, 2022

Package DI Number

10891040701173

Quantity per Package

3

Contains DI Package

00891040701176

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard