Powerheart® AED G3 Plus Semi Automatic

Basic Information

• Brand Name: Powerheart® AED G3 Plus Semi Automatic
• Primary DI: 00812394021147
• Version / Model: 9390E-1001-TSO
• Catalog Number: 9390E-1001-TSO
• Company Name: Zoll Medical Corporation
• Labeler DUNS: 055363428
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 4
• Public Version Date: 2022-02-08
• Public Version Status: Update
• Public Device Record Key: 2e336afb-3309-4a5b-a158-e9a5805a87c6

Device Description

G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and TSO battery

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	870.5310	3

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812394021147	GS1
Previous	00812394020386	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102496	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 57 – 103 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: 0 – 50 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 57 – 103 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -30 – 65 Degrees Celsius