Catalog Number

-

Brand Name

Cleveland Multiport Ventricular Catheter Set

Version/Model Number

A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K161731,K161731

Product Code

HCA

Product Code Name

Catheter, Ventricular

Public Device Record Key

5e8ce1f9-d904-4ccf-ab3f-1c57a4e8ce3b

Public Version Date

January 24, 2020

Public Version Number

1

DI Record Publish Date

January 16, 2020

Package DI Number

00860002624921

Quantity per Package

1

Contains DI Package

00860002624914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-