Clever Choice - Automatic Blood Pressure Monitor. Arm testing - SIMPLE DIAGNOSTICS INC

Duns Number:004135503

Device Description: Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blo Automatic Blood Pressure Monitor. Arm testing site. Also measures heart rate. Displays Blood Pressure reading as well as a World Health Organization rating of Blood Pressure readings, to easily indicate to user whether their blood pressure is too high or too low, and gives the user an idea of by how much. Backlight Display.

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More Product Details

Catalog Number

98302-0148-13

Brand Name

Clever Choice

Version/Model Number

SDI-1986 BPM - Backlight

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)

Yes

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

7388df82-3547-40d6-b0f7-5255574e3818

Public Version Date

November 08, 2019

Public Version Number

3

DI Record Publish Date

August 10, 2016

Additional Identifiers

Package DI Number

10898302001361

Quantity per Package

24

Contains DI Package

00898302001364

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"SIMPLE DIAGNOSTICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 19