Catalog Number

PR-35063-HPHNM

Brand Name

ARROW

Version/Model Number

IPN033436

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

K113277,K113277

Product Code

LJS

Product Code Name

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

Public Device Record Key

e5d7ec41-e345-404f-b328-adbc1c22cdcf

Public Version Date

September 29, 2021

Public Version Number

8

DI Record Publish Date

October 16, 2015

Package DI Number

30801902101137

Quantity per Package

5

Contains DI Package

00801902101136

Package Discontinue Date

September 27, 2021

Package Status

Not in Commercial Distribution

Package Type

Case