Spacelabs Healthcare - XPREZZON and qube Display Options - SPACELABS HEALTHCARE (WASHINGTON), INC

Duns Number:145581588

Device Description: XPREZZON and qube Display Options

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More Product Details

Catalog Number

-

Brand Name

Spacelabs Healthcare

Version/Model Number

94267

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 25, 2019

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

OUG

Product Code Name

Medical device data system

Device Record Status

Public Device Record Key

403d614e-e3e7-45bd-88e1-b22f42a7d8d0

Public Version Date

October 24, 2022

Public Version Number

4

DI Record Publish Date

September 29, 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