Catalog Number

104834

Brand Name

POWER PULSE

Version/Model Number

104834-002

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

86f6e267-33f1-4e82-83f7-cc67cb9a25eb

Public Version Date

August 09, 2018

Public Version Number

3

DI Record Publish Date

October 09, 2014

Package DI Number

10616258005109

Quantity per Package

5

Contains DI Package

00616258005102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-