Catalog Number

IARK-3

Brand Name

Intussusception Air Reduction Kit with Blue tip

Version/Model Number

IARK-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

KQT

Product Code Name

Evacuator, Gastro-Urology

Public Device Record Key

e8089414-5417-4919-9324-51a1088623f0

Public Version Date

December 26, 2019

Public Version Number

1

DI Record Publish Date

December 18, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-