Catalog Number

-

Brand Name

Custom Healthcare Systems of VA, LLC

Version/Model Number

KM-19796

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

OKE

Product Code Name

Port Introducer Kit

Public Device Record Key

a27be474-32f0-47f0-acd6-abbbcf07e5b2

Public Version Date

April 28, 2021

Public Version Number

1

DI Record Publish Date

April 20, 2021

Package DI Number

20811870034941

Quantity per Package

4

Contains DI Package

00811870034947

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

NA