Catalog Number

-

Brand Name

Smart Blood Pressure Monitor

Version/Model Number

EOC-SBPBT-L(ePA-08B4)

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

K134029,K134029,K134029

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

b3d39ff8-a949-4ab5-9953-4169b579d5cf

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

July 28, 2018

Package DI Number

26947468535713

Quantity per Package

20

Contains DI Package

16947468535716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

20pcs/box