Catalog Number

-

Brand Name

Omnipod 5 Pod

Version/Model Number

POD-BLE-H1-520

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

K203774,K203768,K203768,K203774,K203774,K203768

Product Code

QFG

Product Code Name

Alternate Controller Enabled Insulin Infusion Pump

Public Device Record Key

83f9e052-d144-4469-8ea5-c1bc6b9937e5

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 25, 2022

Package DI Number

10385083000213

Quantity per Package

5

Contains DI Package

10385083000114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 Pack Box