Catalog Number

-

Brand Name

JETi Sterile Tubing Kit, 6 Fr

Version/Model Number

WVTUBE-6AU

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 17, 2019

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

-

Product Code Name

-

Public Device Record Key

e53af120-fe10-431a-b308-d6150b3d6147

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

June 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-