Catalog Number

-

Brand Name

AngioJet™ Ultra Power Pulse™ Kit

Version/Model Number

104834-0020

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

-

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

-

FDA Premarket Submission

-

Product Code

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

0dd76a56-ad1d-46a6-8502-0560d17435f6

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

08714729888970

Quantity per Package

5

Contains DI Package

08714729888963

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-