Catalog Number

-

Brand Name

AUTOTRANSFUSION ACCESSORIES

Version/Model Number

BT074 COD.134 KIT CARDIO

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

K884872,K884872,K884872

Product Code

DTN

Product Code Name

RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Public Device Record Key

17ff73f6-3153-4b9e-b1fd-4d71230938a3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 15, 2015

Package DI Number

18033178105573

Quantity per Package

12

Contains DI Package

08033178105576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX