Catalog Number

-

Brand Name

JETi Peripheral Catheter

Version/Model Number

WV008F

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 18, 2020

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

DXE

Product Code Name

Catheter, Embolectomy

Public Device Record Key

1e95448e-553b-49cd-8227-524b0e66e454

Public Version Date

September 27, 2022

Public Version Number

5

DI Record Publish Date

January 24, 2018

Package DI Number

B139WV008F1

Quantity per Package

1

Contains DI Package

B139WV008F0

Package Discontinue Date

November 18, 2020

Package Status

Not in Commercial Distribution

Package Type

Carton Box