Omnipod 5 Controller APP - Actual downloadable APP, called Omnipod 5 - INSULET CORPORATION

Duns Number:051334402

Device Description: Actual downloadable APP, called Omnipod 5 Controller APP

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More Product Details

Catalog Number

-

Brand Name

Omnipod 5 Controller APP

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K203768,K203772

Product Code Details

Product Code

NDC

Product Code Name

Calculator, Drug Dose

Device Record Status

Public Device Record Key

dc84f06e-2555-4835-a29f-bdf9c0d6589b

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INSULET CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4