Catalog Number

-

Brand Name

CathGrip

Version/Model Number

ENT53002NS

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"

Yes

For Single-Use

Yes

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

KMK

Product Code Name

Device, Intravascular Catheter Securement

Public Device Record Key

e53e902e-5ea1-4596-a49d-cd004ec1cc2d

Public Version Date

June 04, 2020

Public Version Number

1

DI Record Publish Date

May 27, 2020

Package DI Number

10653599001063

Quantity per Package

30

Contains DI Package

00653599001066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box