Catalog Number

-

Brand Name

Tubing Organizer

Version/Model Number

AX-xxxxx

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

-

Product Code

KRI

Product Code Name

ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Public Device Record Key

456b4abc-7a6e-4c42-acda-37207282cac7

Public Version Date

April 21, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2015

Package DI Number

10803622128377

Quantity per Package

10

Contains DI Package

00803622128370

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE