Catalog Number

850-6013SA

Brand Name

Advantage™

Version/Model Number

850-6013SA

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2019

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970211,K970211

Product Code

DPW

Product Code Name

Flowmeter, Blood, Cardiovascular

Public Device Record Key

5291e916-fcad-4ad5-b7b6-d9db7be9c37f

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

September 21, 2016

Package DI Number

00634782553173

Quantity per Package

15

Contains DI Package

00634782053383

Package Discontinue Date

April 15, 2019

Package Status

Not in Commercial Distribution

Package Type

Master Case