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

  • 00884838055704 ()
989803149971

  • Rechargeable professional automated external defibrillator
FR3 Infant/Child Key
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Infant Child Key
In Commercial Distribution

  • 00884838055681 ()
989803150031

  • External defibrillator dose attenuation magnetic switch
IntelliVue G7m Anesthesia Gas Module for use with IntelliVue MP40 to MP90 and MX500/550/600/700/800 monitors
Philips Medizin Systeme Böblingen GmbH
IntelliVue G7m Anesthesia Gas Module
In Commercial Distribution

  • 00884838051492 ()
866173

  • Patient monitoring system module, multiple-gas
OnSite, US English, Super Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860367
Not in Commercial Distribution

  • 00884838051478 ()
860367

  • Non-rechargeable public automated external defibrillator
FR3 ECG, US English, Small Soft, Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860366
Not in Commercial Distribution

  • 00884838051461 ()
860366

  • Non-rechargeable public automated external defibrillator
FR3 Text, US English, Small Soft Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860365
Not in Commercial Distribution

  • 00884838051454 ()
860365

  • Non-rechargeable public automated external defibrillator
FR3 ECG, US English, Rigid System Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860364
Not in Commercial Distribution

  • 00884838051447 ()
860364

  • Non-rechargeable public automated external defibrillator
FR3 Text, US English Rigid System Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860363
Not in Commercial Distribution

  • 00884838051430 ()
860363

  • Non-rechargeable public automated external defibrillator
FR3 ECG, US English, Soft System Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
860362
Not in Commercial Distribution

  • 00884838051423 ()
860362

  • Non-rechargeable public automated external defibrillator
FR3 Text, US English, Soft System Bundle
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861499
Not in Commercial Distribution

  • 00884838051416 ()
861499

  • Non-rechargeable public automated external defibrillator
Guideline 2005 Exch, FR2+ Text, Philips
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861365
Not in Commercial Distribution

  • 00884838050730 ()
861365

  • Non-rechargeable public automated external defibrillator
Guideline 2005 Exch, FR2+ ECG, Philips
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
861364
Not in Commercial Distribution

  • 00884838050723 ()
861364

  • Non-rechargeable public automated external defibrillator
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
FR2 ECG Assessment Module, AAMI
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
M3873A
Not in Commercial Distribution

  • 00884838049956 ()


  • Electrocardiographic lead set, reusable
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 Defibrillator, HS1
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
M5066A
Not in Commercial Distribution

  • 00884838049123 ()


  • Non-rechargeable public automated external defibrillator
FR3 Aviation Battery Pack
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 FAA Compliant Battery
Not in Commercial Distribution

  • 00884838048607 ()
989803150171

  • Primary battery
No Description
Philips Medical Systems Hsg
860398
Not in Commercial Distribution

  • 00884838045927 ()
860398

  • Rechargeable professional automated external defibrillator
No Description
Philips Medical Systems Hsg
860397
Not in Commercial Distribution

  • 00884838045910 ()
860397

  • Rechargeable professional automated external defibrillator
No Description
Philips Medical Systems Hsg
860396
Not in Commercial Distribution

  • 00884838045903 ()
860396

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

  • 00884838041547 ()
861487

  • Emergency/ambulatory healthcare software
Infant/Child Key
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FRx Infant Child Key
In Commercial Distribution

  • 00884838038004 ()
989803139311

  • External defibrillator dose attenuation magnetic switch
Heartstream Pads to CodeMaster Adapter
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
05-10200
Not in Commercial Distribution

  • 00884838037984 ()


  • Electrocardiographic lead switching adaptor
Heartstream Pads to Zoll Adapter
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
05-10100
In Commercial Distribution

  • 00884838037977 ()


  • Electrocardiographic lead switching adaptor
Heartstream Pads to QUIK-COMBO Adapter
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
05-10000
In Commercial Distribution

  • 00884838037960 ()


  • Electrocardiographic lead switching adaptor
CPR meter adhesives, 10 pack
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
CPR Meter Patient Adhesive Pads
Not in Commercial Distribution

  • 00884838035256 ()
  • 00884838116689 ()
989803163291

  • Dressing-fixation skin adhesive tape, non-silicone
Secondary Rechargeable Battery
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Secondary Rechargeable Battery
Not in Commercial Distribution

  • 00884838035096 ()
989803150241

  • Secondary battery
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
QCPR METER, BUNDLE ASSY
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
989803149941
Not in Commercial Distribution

  • 00884838034648 ()


  • Cardiopulmonary resuscitation feedback device, electronic
No Description
Philips Medical Systems Hsg
861491
Not in Commercial Distribution

  • 00884838027961 ()
861491

  • Rechargeable professional automated external defibrillator
Primary Battery
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR3 Primary Battery
Not in Commercial Distribution

  • 00884838023857 ()
989803150161

  • Primary battery
Primary Battery
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HS1 Primary Battery
Not in Commercial Distribution

  • 00884838023840 ()
M5070A

  • Primary battery
FR2+ Battery, Long Life LiMNO2
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR2 Primary Battery
Not in Commercial Distribution

  • 00884838023833 ()
M3863A

  • Primary battery
FR2+ Battery, rechargeable LiION
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FR2 Rechargeable Battery
Not in Commercial Distribution

  • 00884838023826 ()
M3848A

  • Secondary battery
FRx Aviation Battery Pack
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
FRx Aviation Battery
In Commercial Distribution

  • 00884838023802 ()
989803139301

  • Primary battery
FR2+ Battery-Aviation-LiMnO2
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
TSO C-142 Primary Battery
Not in Commercial Distribution

  • 00884838023789 ()
989803136291

  • Primary battery
HeartStart Infant/Child SMART Pads Cartridge
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Heartstart Infant Child Smart Pads Cart.
Not in Commercial Distribution

  • 00884838023758 ()
M5072A

  • External defibrillation electrode, paediatric, single-use
FR2 Infant/Child Reduced Energy Pads
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
HeartStart Pediatric Pads FR2
In Commercial Distribution

  • 00884838023734 ()
M3870A

  • External defibrillation electrode, paediatric, single-use
HeartStart XL+ Defibrillator/Monitor
Philips Medical Systems Hsg
861290
Not in Commercial Distribution

  • 00884838023680 ()
861290

  • Rechargeable professional automated external defibrillator
No Description
Philips Medical Systems Hsg
861482
Not in Commercial Distribution

  • 00884838023659 ()
861482

  • Rechargeable professional automated external defibrillator
Infant Pads AAMI Barrel Conn.
Philips Medical Systems Hsg
989803106951
In Commercial Distribution

  • 00884838022034 ()
M3504A

  • External defibrillation electrode, paediatric, single-use
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