Catalog Number

CDC-45541-VPS

Brand Name

ARROW

Version/Model Number

IPN036772

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"

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

K122545,K122545

Product Code

LJS

Product Code Name

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

Public Device Record Key

2174624b-e2de-4b87-a9b4-55bc2b4eb952

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

August 23, 2017

Package DI Number

30801902124082

Quantity per Package

3

Contains DI Package

20801902124085

Package Discontinue Date

November 05, 2018

Package Status

Not in Commercial Distribution

Package Type

Case