blood pressure monitor - BETTER BASICS, INC.

Duns Number:013029698

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More Product Details

Catalog Number

-

Brand Name

blood pressure monitor

Version/Model Number

MP-BPM20A-US

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

K101681,K101681,K101681

Product Code Details

Product Code

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Device Record Status

Public Device Record Key

d089c8f9-06d3-45c4-93b0-c6166bfd6c88

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

November 18, 2016

Additional Identifiers

Package DI Number

00817746020014

Quantity per Package

1

Contains DI Package

00817746020007

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BETTER BASICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2