Catalog Number

-

Brand Name

sunmark

Version/Model Number

BPAG1-20SMARK

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

K193259,K193259

Product Code

DXQ

Product Code Name

Blood Pressure Cuff

Public Device Record Key

efb2a03d-daab-426b-8a68-02ac1635faf3

Public Version Date

August 27, 2020

Public Version Number

2

DI Record Publish Date

August 17, 2020

Package DI Number

10010939953831

Quantity per Package

12

Contains DI Package

00010939953834

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-