Catalog Number

-

Brand Name

Oasis

Version/Model Number

T-PORT-MB

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

0fb0b90d-3905-4906-b792-6f7dd0116890

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 05, 2016

Package DI Number

B031TPORTMB1

Quantity per Package

100

Contains DI Package

B031TPORTMB0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box