FDA.report

AED Manager, Powerheart G5

Primary DI
00812394020188
Brand
AED Manager, Powerheart G5
Company
Cardiac Science Corporation
Model
XAEDMGR01D
Catalog number
XAEDMGR01D
Device description
Event Reporting and Administrative AED Configuration Software V.2.1.0.6 for Powerheart G5
Published
2015-04-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MKJAutomated External Defibrillators (Non-Wearable)

Product Code Classifications

CodeDeviceSpecialtyClass
MKJAutomated External Defibrillators (Non-Wearable)Cardiovascular3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812394020188PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812394020188008123940201888123940201880812394020188

GMDN Terms

TermDefinition
External defibrillator application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a defibrillator intended for external use on the thorax so that it may function according to its intended purpose. A basic set of applications programs and routines are included with the defibrillator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.

Sterilization Methods

Method

Contacts

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
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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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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