Veridian - SmartHeart Automatic Wrist Digital Blood Pressure - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: SmartHeart Automatic Wrist Digital Blood Pressure Monitor

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More Product Details

Catalog Number

-

Brand Name

Veridian

Version/Model Number

01-541

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

001d9e92-af2c-4079-847a-c0ad93c89c88

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

September 11, 2017

Additional Identifiers

Package DI Number

10845717007709

Quantity per Package

12

Contains DI Package

30845717007703

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"VERIDIAN HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 127