Catalog Number

VH-5001

Brand Name

Vasoshield

Version/Model Number

VH-5001

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

GBX

Product Code Name

Catheter, Irrigation

Public Device Record Key

d3327ffb-963a-45a3-b776-7a243224e697

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00607567700462

Quantity per Package

5

Contains DI Package

00607567700468

Package Discontinue Date

May 29, 2018

Package Status

Not in Commercial Distribution

Package Type

5 pack box