HoMedics - Arm Type blood pressure monitor - HEALTH & LIFE CO., LTD.

Duns Number:657836743

Device Description: Arm Type blood pressure monitor

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More Product Details

Catalog Number

-

Brand Name

HoMedics

Version/Model Number

BPA-065

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

K050491,K050491

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

60872fad-4fd6-410b-852c-6d3e9f955aca

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

April 01, 2019

Additional Identifiers

Package DI Number

14719872483233

Quantity per Package

4

Contains DI Package

04719872483236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"HEALTH & LIFE CO., LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 37