Catalog Number

-

Brand Name

DATA MASTER

Version/Model Number

V38 SAT - 3/8 x 3/8

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

K092463,K092463

Product Code

DTQ

Product Code Name

CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Public Device Record Key

dbaeed7f-eb8e-46e1-a328-ffabe41c3a99

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 21, 2016

Package DI Number

38033178104716

Quantity per Package

50

Contains DI Package

08033178104715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX