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) (9) PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE) (DRO) (6) Dc-defibrillator, low-energy, (including paddles) (LDD) (4) Electrocardiograph (DPS) (4) ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE (CCK) (3) Oximeter (DQA) (3) MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) (DRT) (3) COMPUTER, BLOOD-PRESSURE (DSK) (3) AID, CARDIOPULMONARY RESUSCITATION (LIX) (2) SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE (DXN) (1)

Premarket Exempt

No Yes

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ONESTEP PEDIARIC CPR MULTI-FUNCTION ELECTRODE, SIN - 00847946099640 Catalog Number :

Device Description : ONESTEP CPR II MULTI-FUNCTION ELECTRODE, SINGLE

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : LIX, MKJ

Prescription Use : No

Device Count : 1

X SERIES - 00847946099657 Catalog Number :

Device Description : Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, NIBP, SPO2, SPCO, TEMP CPR EXPANSION PACK AND ETCO2, W/CP2, DMST

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : DSK, DRT, DQA, CCK, MKJ, DRO

Prescription Use : No

Device Count : 1

ONESTEP CPR II ADULT MULTI-FUNCTION ELECTRODE, SIN - 00847946099664 Catalog Number :

Device Description : ONESTEP ADULT CPR SENSOR, SINGLE

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : LIX, MKJ

Prescription Use : No

Device Count : 1

ZOLL MFC - 00847946099671 Catalog Number :

Device Description : CABLE ASSY, MFC-CPRD, X SERIES

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : CCK, DSK, DRT, DQA, DXN

Prescription Use : No

Device Count : 1

E SERIES - 00847946099688 Catalog Number :

Device Description : Defibrillator ,MAIN, AED-1, 12 LEAD, SPO2/ETCO2/NIBP, BT/GPS, PACE, AC, NO RAILS, DMST

Device Class : 3

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

X SERIES - 04560233592995 Catalog Number :

Device Description : Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NIBP, NIBP-MO Defibrillator ,MAIN ASSY, X SERIES MONITOR/DEFIBRILLATOR 3/5 LEAD, NIBP, NIBP-MOD-G, SPO2, CPR EXPANSION PACK AND ETCO2, JAPAN

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : MKJ, DSK, CCK, DQA, DRT, DRO

Prescription Use : No

Device Count : 1

R Series - 04560233593008 Catalog Number :

Device Description : MAIN, R SERIES, ALS, WI-FI, 3/5 LD, AC PWR, STD ECG, CF/USB, JAPANESE

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : LDD, DRO, DPS, MKJ

Prescription Use : No

Device Count : 1

R Series - 04560233593015 Catalog Number :

Device Description : MAIN, R SERIES, ALS, WI-FI, 3/5 LD, AC PWR, SP02, STD ECG, CF/USB, JAPANESE

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : DPS, DRO, MKJ, LDD

Prescription Use : No

Device Count : 1

R Series - 04560233593022 Catalog Number :

Device Description : MAIN, R SERIES, ALS, WI-FI, 3/5 LD, AC PWR, PACE, STD ECG, CF/USB, JAPANESE

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : LDD, DPS, MKJ, DRO

Prescription Use : No

Device Count : 1

R Series - 04560233593046 Catalog Number :

Device Description : MAIN, R SERIES, ALS, WI-FI, 3/5 LD, AC PWR, SP02, STD ECG, CF/USB, JAPANESE

Device Class : 2

Duns Number: 055363428

Premarket Exempt : No

Product Code : DPS, DRO, LDD, MKJ

Prescription Use : No

Device Count : 1

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