Catalog Number

-

Brand Name

sunmark

Version/Model Number

BP3NM1-3WSMARK

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

-

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

7c2420d9-ffdd-4078-977d-34b5fb187121

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

August 07, 2020

Package DI Number

10010939953794

Quantity per Package

6

Contains DI Package

00010939953797

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-