Catalog Number

CK000641

Brand Name

Per-Q-Cath

Version/Model Number

CK000641

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LJS

Product Code Name

Catheter,intravascular,therapeutic,long-term greater than 30 days

Public Device Record Key

5f6bc2d5-45c3-4b11-a1cb-0ec9439cb023

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

March 30, 2016

Package DI Number

10801741127691

Quantity per Package

5

Contains DI Package

00801741127694

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA