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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Lithium replacement battery for Philips(TM) Heartstart(TM) FRx Onsite & Home(TM) AED.
Amco International Manufacturing & Design, Inc.
AM5070
In Commercial Distribution

  • 00853258006054 ()
AM5070

  • Primary battery
Lithium replacement battery for Philips(TM) HeartStart(TM) FR2 and FR2+
Amco International Manufacturing & Design, Inc.
6L785
In Commercial Distribution

  • 00853258006047 ()
6L785

  • Primary battery
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.
Amco International Manufacturing & Design, Inc.
AM9146-2
In Commercial Distribution

  • 00853258006030 ()
AM9146-2

  • Primary battery
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.
Amco International Manufacturing & Design, Inc.
AM9146-1
In Commercial Distribution

  • 00853258006023 ()
AM9146-1

  • Primary battery
Lithium replacement battery for Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D
Amco International Manufacturing & Design, Inc.
AM9141
In Commercial Distribution

  • 00853258006016 ()
AM9141

  • Primary battery
Lithium replacement battery for Physio-Control LifePak 500(TM) AED
Amco International Manufacturing & Design, Inc.
5L500
In Commercial Distribution

  • 00853258006009 ()
5L500

  • Primary battery
No Description
ZOLL MANUFACTURING CORPORATION
HWD 1000 Monitor
In Commercial Distribution

  • 00855778005159 ()
10A0995

  • Wearable defibrillation system
No Description
ZOLL MANUFACTURING CORPORATION
LifeVest 4000 Electrode Belt
In Commercial Distribution

  • 00855778005135 ()
10A1025

  • Wearable defibrillation system
No Description
ZOLL MANUFACTURING CORPORATION
LifeVest Garment A
In Commercial Distribution

  • 00855778005128 ()
10A0991

  • Wearable defibrillation system
No Description
ZOLL MANUFACTURING CORPORATION
LifeVest Garment B
In Commercial Distribution

  • 00855778005111 ()
10A1004

  • Wearable defibrillation system
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