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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Clear

Powerheart® AED G3 Pro AED, Stocking Package - 00812394021062 Catalog Number : 9300P-1001SP

Device Description : G3, AED, PRO, AHA 2010 with adult pads and battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Automatic AED - 00812394021079 Catalog Number : 9390A-01

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

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Automatic AED - 00812394021086 Catalog Number : 9390A-1001

Device Description : G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Automatic AED, stocking package - 00812394021093 Catalog Number : 9390A-1001SP

Device Description : G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery, stocking package

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Automatic AED - 00812394021109 Catalog Number : 9390A-1001-TSO

Device Description : G3Plus, AED, Automatic, AHA 2010, with adult pads and TSO battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Semi-Automatic AED - 00812394021116 Catalog Number : 9390E-01

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

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Semi Automatic - 00812394021123 Catalog Number : 9390E-1001

Device Description : G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Semi Automatic Stocking Package - 00812394021130 Catalog Number : 9390E-1001SP

Device Description : G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and battery, stocking package

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® AED G3 Plus Semi Automatic - 00812394021147 Catalog Number : 9390E-1001-TSO

Device Description : G3Plus, AED, Semi Automatic, AHA 2010, with adult pads and TSO battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart® G5 Automatic AED - 00812394021154 Catalog Number : G5A-01A

Device Description : Powerheart G5 AED, Fully Automatic, English, with Intellisense Adult Pads and Battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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