DEVICE: AED 3 (00847946048273)
Device Identifier (DI) Information
AED 3
1128-001206-12
In Commercial Distribution
Zoll Medical Corporation
1128-001206-12
In Commercial Distribution
Zoll Medical Corporation
MAIN ASSEMBLY, AVIATION, BLS, ZOLL AED 3, INT'L ENGLISH ERC
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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48049 | Non-rechargeable professional semi-automated external defibrillator |
A portable electronic device designed to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, and to audibly/visually instruct an operator to enable it to activate defibrillation of the heart or allow the operator to decide when to activate defibrillation based on its electrocardiogram display. It is intended to be used by healthcare professionals (e.g., paramedics, medical staff) in healthcare settings. It consists of an external pulse generator (EPG) and skin-adhesive electrodes to monitor the rhythm/deliver the shocks; it has internal non-rechargeable batteries that must be replaced when indicated.
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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
2f030613-4a5f-4340-868b-bf80ee3340bd
March 22, 2022
1
March 14, 2022
March 22, 2022
1
March 14, 2022
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
[?]
No Customer Contact currently defined