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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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Guidelines Update, FRx
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861339
Not in Commercial Distribution

  • 00884838050716 ()
861339

  • Non-rechargeable public automated external defibrillator
Guidelines Update, New FRx
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861338
Not in Commercial Distribution

  • 00884838050709 ()
861338

  • Non-rechargeable public automated external defibrillator
Guidelines Update, HS1
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861335
Not in Commercial Distribution

  • 00884838050686 ()
861335

  • Non-rechargeable public automated external defibrillator
Guidelines Update, New HS1
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861334
Not in Commercial Distribution

  • 00884838050679 ()
861334

  • Non-rechargeable public automated external defibrillator
HS Refurbished FR2+ AED, no ECG
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861459
Not in Commercial Distribution

  • 00884838050396 ()
861459

  • Non-rechargeable public automated external defibrillator
HS Refurbished FR2+ AED, with ECG
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861458
Not in Commercial Distribution

  • 00884838050389 ()
861458

  • Non-rechargeable public automated external defibrillator
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 FR3 Defibrillator
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart FR3
In Commercial Distribution

  • 00884838049994 ()
861389

  • Rechargeable professional automated external defibrillator
HeartStart FR3 Defibrillator
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart FR3
In Commercial Distribution

  • 00884838049987 ()
861388

  • Rechargeable professional automated external defibrillator
FR2 ECG Assessment Module
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
M3874A
Not in Commercial Distribution

  • 00884838049963 ()


  • Electrocardiographic lead set, reusable
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