Catalog Number

18239

Brand Name

Omnipod (Dash) Display App.

Version/Model Number

1.3.1

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PKU

Product Code Name

Insulin Pump Secondary Display

Public Device Record Key

2f4cb276-8c75-4958-880a-83cc0bcd4460

Public Version Date

March 01, 2021

Public Version Number

1

DI Record Publish Date

February 20, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-