Catalog Number

194607H

Brand Name

Manifold Kit

Version/Model Number

194607H

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

OEZ

Product Code Name

Cardiovascular Procedure Kit

Public Device Record Key

da10e0a6-e43d-461d-8309-c8358211b14d

Public Version Date

January 23, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20886333208214

Quantity per Package

10

Contains DI Package

00886333208210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box