Catalog Number

19191

Brand Name

Omnipod

Version/Model Number

ZXP420

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LZG

Product Code Name

Pump, Infusion, Insulin

Public Device Record Key

d9894619-6b84-4124-9962-5f013833da1a

Public Version Date

February 22, 2021

Public Version Number

3

DI Record Publish Date

March 05, 2018

Package DI Number

20385081120033

Quantity per Package

10

Contains DI Package

10385081120036

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box