DEVICE: ZENIX (00847946056094)
Device Identifier (DI) Information
ZENIX
9500-000131-12
In Commercial Distribution
Zoll Medical Corporation
9500-000131-12
In Commercial Distribution
Zoll Medical Corporation
CABLE, LIMB LEAD ECG, IEC
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
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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42489 | Electrocardiographic electrode, reusable |
A noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, or adhesive tape, and a conductive gel (some are pre-gelled), or using a suction mechanism; alternatively, some types may be designed to be attached to hand-held heart rate meters. Electrocardiography (ECG) is usually performed using a set of electrodes (e.g., 12) connected to appropriate leads and cables. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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MKJ | Automated external defibrillators (non-wearable) |
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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Handling Environment Temperature: exactly 0 Degrees Celsius |
Storage Environment Humidity: exactly 0 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: more than 0 KiloPascal |
Storage Environment Temperature: exactly 0 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3ae0fb7e-709f-4307-b726-d04645d45ab0
December 20, 2024
1
December 12, 2024
December 20, 2024
1
December 12, 2024
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined