Catalog Number

PR-45563-TTS

Brand Name

ARROW

Version/Model Number

IPN037470

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

K160925,K160925

Product Code

LJS

Product Code Name

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

Public Device Record Key

e4eb4aa4-5cf2-4206-bf26-3e6261710eeb

Public Version Date

October 20, 2021

Public Version Number

5

DI Record Publish Date

October 01, 2018

Package DI Number

40801902125697

Quantity per Package

5

Contains DI Package

30801902125690

Package Discontinue Date

October 18, 2021

Package Status

Not in Commercial Distribution

Package Type

Case