Zoll Medical Corporation

Address:269 MILL ROAD,CHELMSFORD,MA,01824,US

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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

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Powerheart® Pro Battery - 00812394020867 Catalog Number : 9145-301

Device Description : IntelliSense lithium battery: For Powerheart® G3 Pro model 9300P with 1 year ful IntelliSense lithium battery: For Powerheart® G3 Pro model 9300P with 1 year full replacement guarantee

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Battery - 00812394020874 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: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Battery - 00812394020881 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: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G3 TSO Battery - 00812394020898 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: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense® Battery Powerheart® G5 - 00812394020904 Catalog Number : XBTAED001A

Device Description : Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full rep Intellisense non-rechargeable battery for Powerheart G5 AED with 4 year full replacement guarantee

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® Adult Defibrillation Pads - 00812394020911 Catalog Number : 9131-001

Device Description : Defibrillation Pads(adult) with two-year shelf life for full range of Powerheart® AEDs

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® Polarized Adult Defibrillation Pads - 00812394020928 Catalog Number : 9660-001

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

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® Pediatric Pads - 00812394020935 Catalog Number : 9730-002

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

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense Adult Defibrillation Pads, Powerheart® G5 - 00812394020942 Catalog Number : XELAED001A

Device Description : Intellisense Adult defibrillation Pads, non-polarized, for Powerheart® G5

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense Adult Defibrillation Pads, Powerheart® G5 - 00812394020959 Catalog Number : XELAED001B

Device Description : Intellisense Adult defibrillation Pads, non-polarized, for Powerheart® G5

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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