SphygmoCor - Packaged SphygmoCor XCEL systems including - ATCOR MEDICAL PTY LTD

Duns Number:751626706

Device Description: Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plu Packaged SphygmoCor XCEL systems including assembly module EM4 with UDI Direct Marking plus various components (SphygmoCor XCEL software DVD, product information DVD, tonometer, power cord/adapter, BP cuffs, and others).CONFIGURATIONS ENCOMPASSED BY THE XCEL VERSION/MODEL:• XCEL-PWA Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) only].• XCEL-PWV Configuration: [SphygmoCor software configured for pulse wave velocity (PWV) only].• XCEL-PWA+PWV Configuration: [SphygmoCor software configured for pulse wave analysis (PWA) and pulse wave velocity (PWV)].

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More Product Details

Catalog Number

-

Brand Name

SphygmoCor

Version/Model Number

XCEL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122129,K122129

Product Code Details

Product Code

DSK

Product Code Name

Computer, Blood-Pressure

Device Record Status

Public Device Record Key

1b7eaf99-cf02-426d-8833-6c9a77536c48

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-