Catalog Number

6021NKIT

Brand Name

Advantage™

Version/Model Number

6021NKIT

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

K041411,K041411

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

cf684cbb-5396-4504-a522-b009d12c1fbf

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

May 23, 2019

Package DI Number

00634782596590

Quantity per Package

5

Contains DI Package

00634782095215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case