ABP - 90217/90217A Ultralite ABP Monitor, Ambulatory - SPACELABS HEALTHCARE (WASHINGTON), INC

Duns Number:145581588

Device Description: 90217/90217A Ultralite ABP Monitor, Ambulatory Blood Pressure

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More Product Details

Catalog Number

N/A

Brand Name

ABP

Version/Model Number

90217

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

-

Product Code Details

Product Code

DXN

Product Code Name

SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Device Record Status

Public Device Record Key

c11c3d67-e0e6-433e-96c4-f11eafde1ab2

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

October 21, 2016

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