Catalog Number

-

Brand Name

VENDYS II

Version/Model Number

JK-001V

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 24, 2027

Issuing Agency

In HIBCC

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

-

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

9716bc41-2cbe-42f2-b4b9-4ffd699dc80b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-