Catalog Number

-

Brand Name

Sunmark

Version/Model Number

BP3MR1-1HSMARK

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)

-

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

1d54982d-f556-43da-8593-07443b4ecc92

Public Version Date

June 11, 2020

Public Version Number

4

DI Record Publish Date

March 24, 2017

Package DI Number

10038703919050

Quantity per Package

12

Contains DI Package

00038703919053

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton packing