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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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X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2231011-01-661
In Commercial Distribution

  • 00812394026142 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2221511-01-663
In Commercial Distribution

  • 00812394026135 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2221511-01-662
In Commercial Distribution

  • 00812394026128 ()


  • Rechargeable professional automated external defibrillator
X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2221511-01-661
In Commercial Distribution

  • 00812394026111 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2221011-01-663
In Commercial Distribution

  • 00812394026104 ()


  • Rechargeable professional automated external defibrillator
X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2221011-01-662
In Commercial Distribution

  • 00812394026098 ()


  • Rechargeable professional automated external defibrillator
CABLE, MFC, THOR, EC53
Zoll Medical Corporation
9500-000129
In Commercial Distribution

  • 00812394022823 ()


  • Electrocardiographic electrode connector
M6-C Implant Case Kit – Standard
Spinal Kinetics, Inc.
FG 0168
In Commercial Distribution

  • 00812388031305 ()
ICC-0000-20

  • Cervical total intervertebral disc prosthesis, modular
SurVeil DCB 6.0mm x 120mm x 135cm
Surmodics, Inc.
SRV03513506012
In Commercial Distribution

  • 00812339030494 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
SurVeil DCB 6.0mm x 60mm x 135cm
Surmodics, Inc.
SRV03513506060
In Commercial Distribution

  • 00812339030463 ()

  • Balloon Diameter: 6 Millimeter
  • Balloon Length: 60 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
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