ABP - Ambulatory Blood Pressure (ABP) Report Management - SPACELABS HEALTHCARE (WASHINGTON), INC

Duns Number:145581588

Device Description: Ambulatory Blood Pressure (ABP) Report Management System

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More Product Details

Catalog Number

N/A

Brand Name

ABP

Version/Model Number

92506

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 15, 2017

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

7622551a-5399-4316-8b2f-130edcf23243

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 11, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPACELABS HEALTHCARE (WASHINGTON), INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 732