Catalog Number

-

Brand Name

Bashir™ Endovascular Catheter

Version/Model Number

7201

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

K183290,K183290

Product Code

KRA

Product Code Name

Catheter, Continuous Flush

Public Device Record Key

1819cd34-31a3-48e4-90ff-5f802c8bc179

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 10, 2019

Package DI Number

10850005115004

Quantity per Package

16

Contains DI Package

00850005115007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-