Catalog Number

18900-5A

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

b792a22a-86cc-4767-ad74-2330a5785b68

Public Version Date

September 12, 2018

Public Version Number

2

DI Record Publish Date

March 05, 2018

Package DI Number

20385081120019

Quantity per Package

1

Contains DI Package

10385081120012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Starter Kit