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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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XVIVO Disposable Lung Kit - 07350069520401

The XVIVO Lung Disposables Kit contains a number of single-use, disposable sterile and non-sterile items intended to be used with the XVIVO Perfusion System (XPS™) for ex vivo reconditioning of donor lungs.
Xvivo Perfusion AB
19046
In Commercial Distribution

  • 07350069520401 ()
19046

  • Lung donor-organ preservation/evaluation system lung-interface set

Esteem MedCem - 00812282020603

MedCem Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020603 ()
901610-301

  • Fully-implantable middle ear implant system

X SERIES - 00812394026272

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB, (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2231511-01-664
In Commercial Distribution

  • 00812394026272 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026265

DEVICE IDENTIFIER, X SERIES MONITOR/DEFIBRILLATOR W/PACING, 12 LEAD W/INTERP, SPO2, NIBP, IBP/TEMP, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2221511-01-664
In Commercial Distribution

  • 00812394026265 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026258

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2231011-01-664
In Commercial Distribution

  • 00812394026258 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026241

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 4, CONTAINS 610)
Zoll Medical Corporation
601-2221011-01-664
In Commercial Distribution

  • 00812394026241 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026197

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB, (TIER 3)
Zoll Medical Corporation
601-2231511-01-663
In Commercial Distribution

  • 00812394026197 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026180

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB (TIER 2)
Zoll Medical Corporation
601-2231511-01-662
In Commercial Distribution

  • 00812394026180 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026173

X SERIES MONITOR/DEFIBRILLATOR 12 LEAD/W INTERP, PACING, NIBP, SPO2, SPCO, IBP/TEMP CPR EXPANSION PACK AND ETCO2, DMST, REFURB (TIER 1)
Zoll Medical Corporation
601-2231511-01-661
In Commercial Distribution

  • 00812394026173 ()


  • Rechargeable professional automated external defibrillator

X SERIES - 00812394026166

X SERIES, MONITOR/DEFIBRILLATOR, 12 LD W/ INTERP, ECG, PACING, NIBP, SPO2, SPCO, CPR EXPANSION PACK, ETCO2, DMST, REFURB (TIER 3)
Zoll Medical Corporation
601-2231011-01-663
In Commercial Distribution

  • 00812394026166 ()


  • Rechargeable professional automated external defibrillator
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