Catalog Number

SKT -USA 1-DOO 1-MG-ENG

Brand Name

Omnipod DASH Starter Kit

Version/Model Number

PDM-USA1-DOO1-MG-USA1

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

68e19fa7-6906-4010-a1e1-be6b440f4a75

Public Version Date

February 22, 2021

Public Version Number

4

DI Record Publish Date

July 03, 2018

Package DI Number

20385082000006

Quantity per Package

1

Contains DI Package

10385082000009

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Starter Kit