Catalog Number

-

Brand Name

JETi Peripheral Catheter

Version/Model Number

WV088F-1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 09, 2022

Issuing Agency

In HIBCC

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"

-

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

-

Product Code

QEZ

Product Code Name

Aspiration Thrombectomy Catheter

Public Device Record Key

d9c1cfd6-47e8-4308-81f9-f648ac976000

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

June 17, 2019

Package DI Number

B139WV088F11

Quantity per Package

1

Contains DI Package

B139WV088F10

Package Discontinue Date

June 09, 2022

Package Status

Not in Commercial Distribution

Package Type

Carton