FDA.reportPublic FDA data

Powerheart® AED G3 Plus Automatic AED,

Primary DI
00812394020478
Brand
Powerheart® AED G3 Plus Automatic AED,
Company
Cardiac Science Corporation
Model
9390A-1001SP
Catalog number
9390A-1001SP
Device description
G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery, stocking package
Published
2014-11-10
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
00812394020478PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020478008123940204788123940204780812394020478

GMDN Terms#

Term, Definition table
TermDefinition
Non-rechargeable public 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 automatically activates defibrillation of the heart through application of electrical shocks to the chest surface. The device is placed in conspicuous public locations and is intended to be applied to the patient by a layperson. It consists of an external pulse generator (EPG) with a cardiac rhythm recognition system and a pair of skin-adhesive electrodes to monitor the rhythm and deliver the shocks; it also includes a non-rechargeable battery for energy.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-30 Degrees Celsius65 Degrees Celsius

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
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
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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10847946016354PEDI PADZ IIZoll Medical CorporationMKJ2026-02-11
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