Cardiac Science Corporation

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Automated External Defibrillators (Non-Wearable) (MKJ) (10)

Premarket Exempt

No Yes

Clear

Powerheart® Polarized Adult Defibrillation Pads - 00812394020249 Catalog Number : 9660-001

Device Description : Polarized Defibrillation Pads(adult) with two-year shelf life

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart®Pediatric Pads - 00812394020256 Catalog Number : 9730-002

Device Description : Pediatric defibrillation pads with two-year shelf life

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Battery - 00812394020263 Catalog Number : 9142-301

Device Description : IntelliSense lithium battery: For Powerheart AED G3 model 9300E shipped before A IntelliSense lithium battery: For Powerheart AED G3 model 9300E shipped before April 12, 2004. with 3 year full replacement guarantee

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

FirstSave AED Battery - 00812394020270 Catalog Number : 9143-301

Device Description : IntelliSense lithium battery for FirstSave AED G3 with 1 year full replacement guarantee

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Battery - 00812394020287 Catalog Number : 9146-301

Device Description : IntelliSense lithium battery (white): For Powerheart AED G3 model 9300E and 9300 IntelliSense lithium battery (white): For Powerheart AED G3 model 9300E and 9300A shipped after April 12, 2004 with 4 year full replacement guarantee

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Battery - 00812394020294 Catalog Number : 9146-302

Device Description : IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and 9390 A/E shipped after April 12, 2004 with 4 year full replacement guarantee.

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 TSO Battery - 00812394020300 Catalog Number : 9147-201-TSO

Device Description : IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 IntelliSense lithium battery: For all Cardiac Science AEDs excluding the AED G3 Pro. TSO-C142A certified with 2 year full replacement guarantee.

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Cardiovive AT AED Battery - 00812394020317 Catalog Number : 9146-303

Device Description : IntelliSense lithium battery for Cardiovive AT AED with 4 year warranty

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Cardiovive DM AED Battery - 00812394020324 Catalog Number : 9143-302

Device Description : IntelliSense lithium battery for Cardiovive DM AED with 1 year full warranty

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Automatic AED - 00812394020331 Catalog Number : 9390A-01

Device Description : G3 Plus, AED, Automatic, AHA 2010

Device Class : 3

Duns Number: 190713797

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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