SPACELABS HEALTHCARE - NIBP,HOSE ASSY,ADULT,QUICK RELEASE - SPACELABS HEALTHCARE (WASHINGTON), INC

Duns Number:145581588

Device Description: NIBP,HOSE ASSY,ADULT,QUICK RELEASE

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More Product Details

Catalog Number

714-0018-00

Brand Name

SPACELABS HEALTHCARE

Version/Model Number

SUPPLY

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103142

Product Code Details

Product Code

DXN

Product Code Name

System, measurement, blood-pressure, non-invasive

Device Record Status

Public Device Record Key

5a0aba46-b448-4222-b124-c4e7b04c7ae2

Public Version Date

March 31, 2020

Public Version Number

1

DI Record Publish Date

March 23, 2020

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