Catalog Number

-

Brand Name

Arterial Cannula

Version/Model Number

A282-80A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K162215,K162215

Product Code

DWF

Product Code Name

CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Public Device Record Key

74820aae-ab4e-4d41-a43d-e01b87ce04ef

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

July 17, 2017

Package DI Number

38033178011458

Quantity per Package

10

Contains DI Package

08033178011457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX