Amco International Manufacturing & Design, Inc.

Address:10 Conselyea Street,Brooklyn,NY,11211,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) (7)

Premarket Exempt

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AMCO - 00853258006009 Catalog Number : 5L500

Device Description : Lithium replacement battery for Physio-Control LifePak 500(TM) AED

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

AMCO - 00853258006016 Catalog Number : AM9141

Device Description : Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) 9200RD, 9210 Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

AMCO - 00853258006023 Catalog Number : AM9146-1

Device Description : Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) AED G3 9300A Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) AED G3 9300A,, 9300E shipped after April 12, 2004, with 4 year full replacement guarantee. Color white.

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

AMCO - 00853258006030 Catalog Number : AM9146-2

Device Description : Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) G3 9300A, 93 Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) G3 9300A, 9300E, 9390A, 9390E, shipped after April 12, 2004, with 4 year full replacement guarantee. Color yellow.

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : Yes

Device Count : 1

AMCO - 00853258006047 Catalog Number : 6L785

Device Description : Lithium replacement battery for Philips(TM) HeartStart(TM) FR2 and FR2+

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

AMCO - 00853258006054 Catalog Number : AM5070

Device Description : Lithium replacement battery for Philips(TM) Heartstart(TM) FRx Onsite & Home(TM) AED.

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

AMCO - 00853258006061 Catalog Number : 5L318

Device Description : Lithium replacement battery for Philips(TM) Heartstream ForeRunner(TM) AED (BT1)

Device Class : 3

Duns Number: 830424854

Premarket Exempt : No

Product Code : MKJ

Prescription Use : No

Device Count : 1

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