Catalog Number

616.360.8070-HAV

Brand Name

Tita Jet

Version/Model Number

616.360.8070-HAV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

PXK

Product Code Name

Vascular Access Port Kit

Public Device Record Key

360e3e43-a676-4012-ad8f-179de1c112a0

Public Version Date

June 08, 2021

Public Version Number

1

DI Record Publish Date

May 31, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-