HEARTSINE TECHNOLOGIES LTD

Address:207 AIRPORT ROAD WEST,BELFAST Northern Ireland,GB

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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) (10)

Premarket Exempt

Clear

Pad-Pak - 05060167120466 Catalog Number : PAD-PAK-01

Device Description : Battery and Electrode Cartridge

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

Pediatric-Pak - 05060167120473 Catalog Number : PAD-PAK-02

Device Description : Battery and Electrode Cartridge

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 350P - 05060167120671 Catalog Number : 350-STR-US-10

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 360P - 05060167120688 Catalog Number : 360-STR-US-10

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 450P - 05060167120695 Catalog Number : 450-STR-US-10

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 350P - 05060167120701 Catalog Number : 350-STR-US-AV

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 360P - 05060167120718 Catalog Number : 360-STR-US-AV

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 450P - 05060167120725 Catalog Number : 450-STR-US-AV

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 350P - 05060167120855 Catalog Number : 350-STR-AS-AV

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

HeartSine Samaritan PAD 360P - 05060167120862 Catalog Number : 360-STR-AS-AV

Device Description : Automated External Defibrillator

Device Class : 3

Duns Number: 230479318

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

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