ProCare Automatic Blood Pressure Monitor - Wrist - Automatic Arm Blood Pressure Monitor A31 - ARISE MEDICAL LLC

Duns Number:081149273

Device Description: Automatic Arm Blood Pressure Monitor A31

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More Product Details

Catalog Number

-

Brand Name

ProCare Automatic Blood Pressure Monitor - Wrist

Version/Model Number

240389

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

f0120ddc-932f-4b11-bb1c-511910b6b6c3

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

November 19, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARISE MEDICAL LLC" 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. 17