AccessGUDID - DEVICE: Electrocardiograph (06944413800359)

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Device Identifier (DI) Information

Brand Name: Electrocardiograph
Version or Model: SE-12
Catalog Number:
Company Name: Edan Instruments, Inc.

Primary DI Number: 06944413800359
Issuing Agency: GS1
Device Count: 1

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multichannel electrocardiograph, interpretive, professional	An instrument designed to be used by a healthcare professional in a clinical setting to measure electrical potentials on the body surface to produce a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple-electrode sets (leads) simultaneously, to facilitate interpretation of the record by enabling comparison of multiple-lead recordings of the same heartbeat. It performs a computerized analysis of the signals using an internal algorithm and typically provides a print-out ECG with a suggested interpretation and waveform component measurements.

GMDN Preferred Term Name

GMDN Definition

Multichannel electrocardiograph, interpretive, professional

An instrument designed to be used by a healthcare professional in a clinical setting to measure electrical potentials on the body surface to produce a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from two or more multiple-electrode sets (leads) simultaneously, to facilitate interpretation of the record by enabling comparison of multiple-lead recordings of the same heartbeat. It performs a computerized analysis of the signals using an internal algorithm and typically provides a print-out ECG with a suggested interpretation and waveform component measurements.

FDA Product Code

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Product Code	Product Code Name
DPS	Electrocardiograph

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 01, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Electrocardiograph (06944413800359)