Catalog Number

-

Brand Name

ETEKCITY BLOOD PRESSURE MONITOR

Version/Model Number

EBP-UA5

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

K180435,K180435

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

a052dd26-3740-48f8-aedd-a9ad4563c2a5

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

May 14, 2019

Package DI Number

10817915020026

Quantity per Package

20

Contains DI Package

00817915020029

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case