FDA.reportPublic FDA data

Powerheart® G3 Pro Battery Charger

Primary DI
00812394020096
Brand
Powerheart® G3 Pro Battery Charger
Company
Cardiac Science Corporation
Model
9044-100
Catalog number
9044-100
Device description
Charger, for rechargeable battery: Powerheart® AED G3 Pro model 9300P
Published
2014-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812394020096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020096008123940200968123940200960812394020096

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public semi-automated external defibrillatorA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.262.953.3500techsupport@cardiacscience.com

Regulatory Flags#

DUNS number
190713797
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00847946046118Sunmed721-0013-002021-10-22
00847946046125SunMed712-0014-002021-10-22
00847946046132Sunmed712-0015-002021-10-22
00847946046156Sunmed912-0009-202021-10-22
00847946046163Sunmed912-0010-202021-10-22
00847946046170Sunmed912-0011-202021-10-22
00847946046187Powerheart® G5 ElectrodesXELAED001C2021-08-18
00847946046194Powerheart® G5 ElectrodesXELAED002C2021-08-18
00847946046200Powerheart® G5 ElectrodesXELAED003C2021-08-18
00812394023301Powerheart® AED G3 Plus Automatic AED9390A-1001-TSO9390A-1001-TSO2020-12-02
00812394023172Powerheart® AED G3 Automatic AED9300A-019300A-012020-12-01
00812394023189Powerheart® AED G3 Automatic AED9300A-1001-TSO9300A-1001-TSO2020-12-01
00812394023202Powerheart® AED G3 Semi-Automatic AED9300E-019300E-012020-12-01
00812394023219Powerheart® AED G3 Semi Automatic AED9300E-1001-TSO9300E-1001-TSO2020-12-01
00812394023233Powerheart® AED G3 Pro9300P-019300P-012020-12-01
00812394023240Powerheart® AED G3 Pro AED9300P-10019300P-10012020-12-01
00812394023257Powerheart® AED G3 Pro AED, Stocking Package9300P-1001SP9300P-1001SP2020-12-01
00812394023271Powerheart® AED G3 Plus Automatic AED9390A-019390A-012020-12-01
00812394023288Powerheart® AED G3 Plus Automatic AED9390A-10019390A-10012020-12-01
00812394023295Powerheart® AED G3 Plus Automatic AED, stocking package9390A-1001SP9390A-1001SP2020-12-01

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Primary DI, Brand, Company table
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