Catalog Number

-

Brand Name

JETi All In One Saline Drive Unit

Version/Model Number

WVSDUP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 08, 2021

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

-

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

d767acbf-8903-4ff4-a481-c0f572ca3612

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

February 26, 2021

Package DI Number

WVSDUP2

Quantity per Package

1

Contains DI Package

B139WVSDUP0

Package Discontinue Date

December 08, 2021

Package Status

Not in Commercial Distribution

Package Type

Case