- Physicians Office Resource

RhythmView Workstation, US
RhythmView - 2000

Device Description

An assembly of devices designed to measure, process, and store electronic data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices (e.g., body surface or intracardiac electrocardiograph (ECG) sensors, transducers, and catheters). The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. It typically consists of dedicated workstation, hardware and software that display real-time, three-dimensional (3-D) cardiac maps (e.g., electrical propagation, electrical potential, and cardiac chamber geometry maps), and a catheter.

Environmental Conditions

Special Storage Condition, Specify

Keep Dry

Storage Environment Humidity - Percent (%) Relative Humidity

85.00
10.00

Storage Environment Temperature - Degrees Celsius

45.00
-25.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DQK

Device Name: Computer, Diagnostic, Programmable

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1425

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 00810591020116

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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