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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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LP35,EN-US,MAS-SPO2,MED-CO2,SUN-NIBP,IP-TEMP,WIFI/CELL/LN/CPRIN,STD,BT,STD-PWR
PHYSIO-CONTROL, INC.
70335
In Commercial Distribution

  • 00883873761533 ()
70335-000215

  • Physiologic-monitoring defibrillation system
ASSY PEDIATRIC PADDLE,MULTI LANGUAGE, 3RD EDT
PHYSIO-CONTROL, INC.
11133
In Commercial Distribution

  • 00883873761441 ()
11133-000008

  • External defibrillation electrode, adult, reusable
PADDLE ASSY - HARD PADDLE, ENGLISH,ROHS,LP15
PHYSIO-CONTROL, INC.
11130
In Commercial Distribution

  • 00883873761434 ()
11130-000143

  • External defibrillation electrode, adult, reusable
LP1000 ASSEMBLY BATTERY REPLACEMENT KIT
PHYSIO-CONTROL, INC.
11141
In Commercial Distribution

11141-000100

  • Primary battery
BATTERY, LI-ION, LP35
PHYSIO-CONTROL, INC.
11335
In Commercial Distribution

  • 00883873790144 ()
11335-000001

  • Portable/mobile rechargeable battery pack
LPCR2,USB,H,EN-US,DE,A,1,MODET,FLX,CPR120,A104:0,P30:2,200J,300J,360J,50J,75J,90J,ALRT,US
PHYSIO-CONTROL, INC.
99512
In Commercial Distribution

  • 00883873785911 ()
99512-001434

  • Non-rechargeable public automated external defibrillator
LPCR2,USB,H,EN-US,DE,S,1,MODET,FLX,CPR120,A104:0,P30:2,200J,300J,360J,50J,75J,90J,ALRT,US
PHYSIO-CONTROL, INC.
99512
In Commercial Distribution

  • 00883873785904 ()
99512-001435

  • Non-rechargeable public semi-automated external defibrillator
ASSY, CABLE, THERAPY, LP35
PHYSIO-CONTROL, INC.
11113
In Commercial Distribution

  • 00883873783566 ()
11113-000007

  • External defibrillation electrode, adult, reusable
BATTERY, LPCR2
PHYSIO-CONTROL, INC.
11141
In Commercial Distribution

  • 00883873871560 ()
11141-000163

  • Scalpel, single-use
The Optilume BPH Catheter System is a combination drug/device minimally invasive surgical therapy (MIST) comprised of an uncoated pre-dilation balloon catheter and a separate drug coated balloon (DCB) catheter. The distal end of each catheter has a semi-compliant, inflatable, double lobe balloon that is used to dilate the prostate. The double-lobe DCB catheter is coated with a proprietary coating containing the active pharmaceutical agent paclitaxel. The drug coating covers the working length of the balloon body.
Urotronic, Inc.
1189
In Commercial Distribution

  • 00853095008853 ()

  • Balloon Diameter: 30 Millimeter
  • Balloon Length: 45 Millimeter
  • Balloon Rated Burst Pressure: 4 Atmosphere
1189-30045

  • Urethral dilatation catheter, drug-eluting
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