VERIDIAN - Slim Design Wrist Digital BP Monitor - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: Slim Design Wrist Digital BP Monitor

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More Product Details

Catalog Number

-

Brand Name

VERIDIAN

Version/Model Number

01-511

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

K142088,K142088,K142088

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

34991f4e-4b20-40da-9a47-8c8a7e467fd3

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 26, 2016

Additional Identifiers

Package DI Number

30845717006485

Quantity per Package

3

Contains DI Package

00845717006484

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER 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