Catalog Number

-

Brand Name

PureFlex Arterial Cannulae

Version/Model Number

RA22-2BC Bent flange tip

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

K180979,K180979

Product Code

DWF

Product Code Name

Catheter, cannula and tubing, vascular, cardiopulmonary bypass

Public Device Record Key

d906bf08-c246-4cf3-82b5-d0744b663f0b

Public Version Date

August 05, 2022

Public Version Number

2

DI Record Publish Date

February 05, 2019

Package DI Number

38033178017061

Quantity per Package

10

Contains DI Package

08033178017060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX