Catalog Number

659.75

Brand Name

InnoHaus

Version/Model Number

ABM47 Blood Pressure Monitor with Universal Cuff

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

DXN

Product Code Name

System, Measurement, Blood-Pressure, Non-Invasive

Public Device Record Key

a2cc2301-d5ee-472e-bdee-06597e9fe353

Public Version Date

January 23, 2020

Public Version Number

4

DI Record Publish Date

October 10, 2018

Package DI Number

10853879007826

Quantity per Package

16

Contains DI Package

00853879007829

Package Discontinue Date

January 22, 2020

Package Status

Not in Commercial Distribution

Package Type

Case Pack