Catalog Number

ASK-45541-RWJ4

Brand Name

ARROW

Version/Model Number

IPN036052

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

K112896,K112896

Product Code

LJS

Product Code Name

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

Public Device Record Key

6b2974f8-d288-4be0-8d4b-865b7c465b88

Public Version Date

March 03, 2022

Public Version Number

9

DI Record Publish Date

October 16, 2015

Package DI Number

30801902111440

Quantity per Package

5

Contains DI Package

00801902111449

Package Discontinue Date

March 01, 2022

Package Status

Not in Commercial Distribution

Package Type

Case