Catalog Number

14500-5A

Brand Name

Omnipod

Version/Model Number

UST400

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

-

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

49436ff9-b4d6-4b7e-96e4-df70deed240c

Public Version Date

September 12, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20385081140000

Quantity per Package

1

Contains DI Package

10385081140003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Starter Kit