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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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N/A - 00884838055711

Laerdal System Case, Rigid, FR3
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 System Case, Ridge
Not in Commercial Distribution

  • 00884838055711 ()
989803157531

  • Rechargeable professional automated external defibrillator

HeartStart - 00884838055704

Philips System Case, Rigid, FR3
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 System Case, Ridge
In Commercial Distribution

  • 00884838055704 ()
989803149971

  • Rechargeable professional automated external defibrillator

HeartStart - 00884838055681

FR3 Infant/Child Key
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Infant Child Key
In Commercial Distribution

  • 00884838055681 ()
989803150031

  • External defibrillator dose attenuation magnetic switch

HeartStart - 00884838050006

3-Lead ECG Cable, FR3, AAMI
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
3-Lead ECG Cable, FR3, AAMI
Not in Commercial Distribution

  • 00884838050006 ()
989803150041

  • Electrocardiographic lead set, reusable

HeartStart - 00884838049949

Cable link, FR3 to CPR meter
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Cable Link to Q CPR Meter
Not in Commercial Distribution

  • 00884838049949 ()
989803149951

  • Non-rechargeable professional semi-automated external defibrillator

HeartStart - 00884838048607

FR3 Aviation Battery Pack
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 FAA Compliant Battery
Not in Commercial Distribution

  • 00884838048607 ()
989803150171

  • Primary battery

HeartStart - 00884838038004

Infant/Child Key
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FRx Infant Child Key
In Commercial Distribution

  • 00884838038004 ()
989803139311

  • External defibrillator dose attenuation magnetic switch

HeartStart - 00884838035096

Secondary Rechargeable Battery
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Secondary Rechargeable Battery
Not in Commercial Distribution

  • 00884838035096 ()
989803150241

  • Secondary battery

HeartStart - 00884838034655

3-Lead ECG Cable, FR3, IEC
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
3-Lead ECG Cable, FR3, IEC
Not in Commercial Distribution

  • 00884838034655 ()
989803150051

  • Electrocardiographic lead set, reusable

HeartStart - 00884838023857

Primary Battery
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Primary Battery
Not in Commercial Distribution

  • 00884838023857 ()
989803150161

  • Primary battery
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