Catalog Number

CDA-44041-VPS2

Brand Name

ARROW

Version/Model Number

IPN035422

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

-

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

-

FDA Premarket Submission

K153487,K153487

Product Code

LJS

Product Code Name

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

Public Device Record Key

77770500-f7a0-437f-a251-1d55c18bffc1

Public Version Date

April 22, 2020

Public Version Number

3

DI Record Publish Date

January 22, 2019

Package DI Number

40801902134552

Quantity per Package

3

Contains DI Package

30801902134555

Package Discontinue Date

April 20, 2020

Package Status

Not in Commercial Distribution

Package Type

Case