FDA.report

Powerheart® G3 Pro Rechargeable Battery

Primary DI
00812394020089
Brand
Powerheart® G3 Pro Rechargeable Battery
Company
Cardiac Science Corporation
Model
9144-101
Catalog number
9144-101
Device description
Rechargeable battery: For Powerheart® AED G3 Pro model 9300P with 1 year full replacement guarantee
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

Related Records

Product Codes

CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812394020089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020089008123940200898123940200890812394020089

GMDN Terms

TermDefinition
Secondary batteryA rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.

Sterilization Methods

Method

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
true
Serial number
false
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

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00847946046163Sunmed912-0010-202021-10-22
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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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