DEVICE: Midmark IQecg® Digital ECG (00841709100895)
Device Identifier (DI) Information
Midmark IQecg® Digital ECG
4-000-0061
In Commercial Distribution
4-000-0061
MIDMARK CORPORATION
4-000-0061
In Commercial Distribution
4-000-0061
MIDMARK CORPORATION
The IQecg®from Midmark is an easy-to-use, digital, 12-lead resting ECG solution that helps you quickly administer testing and access patient information you need to make informed cardiac assessments and provide more efficient patient care. Kit includes: Midmark IQecg - USB Version, 10-Lead Patient Cable, 10-Pack Clear ECG Clips, and 100-Pack Disposable EZ-Trode ECG Electrodes.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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16231 | Electrocardiograph, professional, multichannel |
A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.
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FDA Product Code
[?]Product Code | Product Code Name |
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DPS | Electrocardiograph |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight. |
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity |
Handling Environment Temperature: between 15 and 35 Degrees Celsius |
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -15 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 3.5" x 5.7" x 1.2"; Weight: 10.2 oz. |
Device Record Status
d0588ccc-b60f-4e3a-9f60-b668e5ac41be
March 10, 2021
4
September 24, 2016
March 10, 2021
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-624-8950
techsupport@midmark.com
techsupport@midmark.com