Catalog Number

750-4181

Brand Name

VENI-GARD

Version/Model Number

750-4181

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

K935389,K935389,K935389

Product Code

KMK

Product Code Name

DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Public Device Record Key

cba8f76e-779a-468d-a820-f09b15a0f500

Public Version Date

May 06, 2020

Public Version Number

1

DI Record Publish Date

April 28, 2020

Package DI Number

20653405014642

Quantity per Package

150

Contains DI Package

10653405014645

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box