RhythmView - RhythmView Workstation, US, Streaming - ABBOTT

Duns Number:080174723

Device Description: RhythmView Workstation, US, Streaming

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More Product Details

Catalog Number

2002

Brand Name

RhythmView

Version/Model Number

2002

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 07, 2016

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)

Yes

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

DQK

Product Code Name

COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Device Record Status

Public Device Record Key

1ab748fd-65c2-427c-8d5a-679abc33ce9e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 02, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABBOTT" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 14