Catalog Number

-

Brand Name

Custom Healthcare Systems Inc.

Version/Model Number

YMUVC-200

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

OES

Product Code Name

Cardiac Catheterization Kit

Public Device Record Key

ffa486b5-b364-4759-af49-9190812cefad

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

October 03, 2018

Package DI Number

20811870032701

Quantity per Package

12

Contains DI Package

00811870032707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-