Catalog Number

-

Brand Name

Etekcity Smart Blood Pressure Monitor

Version/Model Number

TMB-1583-BS

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

K120058,K120058

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

ea975c1d-9391-4711-a0ce-8c994f008183

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

10817915020156

Quantity per Package

18

Contains DI Package

00817915020159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Carton