DEVICE: AED PLUS (00847946002145)

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Device Record History
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Device Identifier (DI) Information
AED PLUS
20000000000000010
In Commercial Distribution

Zoll Medical Corporation
00847946002145
GS1

1
055363428 *Terms of Use
Defibrillator ,MAIN ASSY, PA SERIES, NO LCD, NO VOICE RCDG, ENGLISH
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Device Characteristics
MR Unsafe
No
No
No
Yes
No
No
No
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?
47910 Non-rechargeable public 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, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. It is placed in conspicuous public locations and is intended to be operated by a layperson. It consists of two skin-adhesive, cartridge-type, disposable electrodes containing non-rechargeable batteries that provide the shock energy, and an electrode-regulating external pulse generator (EPG), which may include a CPR feedback.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MKJ Automated external defibrillators (non-wearable)
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Atmospheric Pressure: more than 0 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Storage Environment Temperature: between -30 and 60 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 5.25" x 9.5" x 11.5"
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Device Record Status
4bb3e089-7757-45f5-8b9c-f9c6af36b101
January 28, 2026
4
September 05, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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