Catalog Number

-

Brand Name

Omnipod PodPals

Version/Model Number

POD-X9-990

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

Yes

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

-

Product Code

KGX

Product Code Name

Tape And Bandage, Adhesive

Public Device Record Key

61723978-b4b6-4b35-a50c-948c8e70b9fd

Public Version Date

February 28, 2022

Public Version Number

2

DI Record Publish Date

July 01, 2019

Package DI Number

20385081120231

Quantity per Package

10

Contains DI Package

10385081120234

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box Adhesive Pads