Catalog Number

JRT-43552-HPHNM

Brand Name

ARROW

Version/Model Number

IPN037626

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

K161765,K161765

Product Code

LJS

Product Code Name

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

Public Device Record Key

42877d0c-8b5b-411f-b9e7-a9f70b5ad8d2

Public Version Date

October 24, 2022

Public Version Number

8

DI Record Publish Date

January 13, 2017

Package DI Number

10801902129311

Quantity per Package

5

Contains DI Package

20801902129318

Package Discontinue Date

February 03, 2020

Package Status

Not in Commercial Distribution

Package Type

Case