PHYSIO-CONTROL, INC.

Address:11811 WILLOWS RD., N.E.,Redmond,WA,98052,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) (6) CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) (DSA) (2) Electrode, electrocardiograph (DRX) (2)

Premarket Exempt

No Yes

Clear

3-wire ECG Cable (AHA) - 00681490579094 Catalog Number : 11110-000029

Device Description : CABLE ASSEMBLY, 3-LEAD ECG, AHA, ROHS

Device Class : 2

Duns Number: 009251992

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 1

3-Wire ECG Cable (IEC) - 00681490579100 Catalog Number : 11110-000030

Device Description : CABLE ASSEMBLY, 3-LEAD ECG, IEC, ROHS

Device Class : 2

Duns Number: 009251992

Premarket Exempt : No

Product Code : DSA

Prescription Use : No

Device Count : 1

EDGE Electrodes with REDI-PAK™ Preconnect System - 00681490580656 Catalog Number : 11996-000017

Device Description : ELECT ASSY-EDGE,QUIK-COMBO REDI-PAK,WW

Device Class :

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

LIFEPAK SLA Battery - 00681490581752 Catalog Number : 11141-000028

Device Description : ASSY-BATTERY,LIFEPAK,SLA

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

Internal Paddle Handle - 00681490583275 Catalog Number : 11131-000001

Device Description : ASSY, PADDLE, INTERNAL HANDLE, WITH UDI

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

QUIK-COMBO Therapy cable to FAST-PATCH® Adapter Cable - 00681490583398 Catalog Number : 11110-000052

Device Description : CABLE ASSY - FAST-PATCH,DOMESTIC

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

QUIK-COMBO Therapy cable to FAST-PATCH® Adapter Cable - 00681490583404 Catalog Number : 11110-000053

Device Description : CABLE ASSY - FAST-PATCH,EUROPE

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

LIFE-PATCH® ECG Electrodes (3/pack) - 00681490587228 Catalog Number : 11100-000001

Device Description : LIFEPATCH ECG ELECT,ADULT 3/PER PAK

Device Class : 2

Duns Number: 009251992

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 1

LIFE-PATCH® ECG Electrodes (4/pack) - 00681490587235 Catalog Number : 11100-000002

Device Description : LIFEPATCH ECG ELECT ADULT 4 PER PAK

Device Class : 2

Duns Number: 009251992

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 1

PEDIATRIC PADDLE ADAPTER - 00681490587853 Catalog Number : 11133-000001

Device Description : PEDIATRIC PADDLE ASSY,ENG, 3RD EDITION

Device Class : 3

Duns Number: 009251992

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

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