Catalog Number

A100-CGO

Brand Name

QardioArm

Version/Model Number

A100

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

K140067,K140067

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

dba56001-6b9a-44d2-815c-2943c0b7527c

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10854894005132

Quantity per Package

12

Contains DI Package

00854894005135

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Masterbox