Catalog Number

-

Brand Name

Oasis

Version/Model Number

IVEXTINJ

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

64a332a8-7a84-4cc0-946b-81608c3c0275

Public Version Date

May 12, 2022

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

B031IVEXTINJ1

Quantity per Package

100

Contains DI Package

B031IVEXTINJ0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-