Catalog Number

897CN-5

Brand Name

Advantage™

Version/Model Number

897CN-5

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"

Yes

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

-

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

624fb113-58d7-43fd-bbe9-cfd5eb50164d

Public Version Date

July 22, 2019

Public Version Number

2

DI Record Publish Date

May 11, 2018

Package DI Number

00634782887070

Quantity per Package

10

Contains DI Package

00634782085674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack