Zoll Medical Corporation

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

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Filters

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) (9) Cable, Electrode (IKD) (1)

Premarket Exempt

No Yes

Clear

Powerheart® G5 Semi Automatic AED - 00812394021260 Catalog Number : G5S-01P1

Device Description : Powerheart® G5 Semi-Automatic AED no battery or pads

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394021277 Catalog Number : G5S-80A

Device Description : Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish), with Intelli Powerheart G5 AED, Semi Automatic, Dual Language (English/Spanish), with Intellisense Adult Pads and Battery

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart G5 Kit, Semi, US Eng/ESP LA - 00812394021284 Catalog Number : G5S-80C

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart G5, Semi, US Eng/ESP LA - 00812394021291 Catalog Number : G5S-80-L

Device Description : Powerheart G5 AED, Semi Automatic, Loaner, Dual Language (English/Spanish)

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Powerheart G5 Semi Auto - 00812394021307 Catalog Number : G5S-80P1

Device Description : Powerheart® G5 Semi Automatic AED, dual language(English/Spanish), no battery or pads

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

AED Manager, V.2.1.1.0 Powerheart G5 - 00812394021314 Catalog Number : XAEDMGR01E

Device Description : Event Reporting and Administrative AED Configuration Software V.2.1.1.0 for Powerheart G5

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

Powerheart® MDLink - 00812394021321 Catalog Number : 400621-046

Device Description : MDLink SW 10.16

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

Powerheart AED G3 Pro ECG Monitoring Cable - 00812394021338 Catalog Number : 5111-101

Device Description : ECG patient monitoring cable (AHA) for Powerheart® AED G3 Pro

Device Class : 2

Duns Number: 055363428

Premarket Exempt : Yes

Product Code : IKD

Prescription Use : Yes

Device Count : 1

Powerheart® G3 Pro Battery Charger Kit - 00812394021345 Catalog Number : 9044-001

Device Description : Charger kit, English, for rechargeable battery: Powerheart AED G3 Pro model 9300P

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Intellisense® Battery Powerheart® G5 - 00812394021369 Catalog Number : XBTAED005A-TSO

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. TSO-C142A certified.

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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