Heart Check Blood Pressure Monitor - Wrist-type fully automatic digital blood pressure - HOME AIDE DIAGNOSTICS, INC.

Duns Number:783518983

Device Description: Wrist-type fully automatic digital blood pressure monitor.

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More Product Details

Catalog Number

DBP-2127

Brand Name

Heart Check Blood Pressure Monitor

Version/Model Number

BP-201M

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

f1e27753-7cb7-4baa-bc2e-8ff1e43fc3d0

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

May 01, 2016

Additional Identifiers

Package DI Number

10891237001079

Quantity per Package

48

Contains DI Package

00891237001072

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"HOME AIDE DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 24
2 A medical device with a moderate to high risk that requires special controls. 44
U Unclassified 11