Catalog Number

CK000401

Brand Name

Poly Per-Q-Cath

Version/Model Number

CK000401

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

64adda9f-a17c-43db-995c-5bfbf5878c44

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

10801741096201

Quantity per Package

3

Contains DI Package

00801741096204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA