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 Type Device Class Implantable

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Abiomed Breethe OXY-1 PLU Disposable
Breethe, Inc.
1000140
In Commercial Distribution

  • 00860001797916 ()
001-0400-100

  • Extracorporeal membrane oxygenator
No Description
Merit Medical Systems, Inc.
00884450732311
In Commercial Distribution

  • 10884450732318 ()
  • 00884450732311 ()

  • Sheath Length (cm)-30 cm (11.8"); Guide Wire Diameter-0.038" (0.97 mm); Sheath Length (cm)-30 cm (11.8"); Sheath French Size (F)-7F
  • Sheath French Size (F)-7F; Guide Wire Diameter-0.038" (0.97 mm); Sheath Length (cm)-30 cm (11.8"); Sheath French Size (F)-7F
  • Guide Wire Diameter-0.038" (0.97 mm)
  • Sheath Length (cm)-30 cm (11.8")
  • Sheath French Size (F)-7F
1000440

  • Vascular catheter introduction set, nonimplantable
Kit, 14Fr Introducer, 13cm and 25cm
Abiomed, Inc.
1000550
In Commercial Distribution

  • 00813502013474 ()
1000550

  • Vascular catheter introduction set, nonimplantable
Kit, Low Profile, 14Fr, 25cm,Sheath Lock
Abiomed, Inc.
1000458
In Commercial Distribution

  • 00813502013269 ()
1000458

  • Vascular catheter introduction set, nonimplantable
Kit, Low Profile, 14Fr, 13cm,Sheath Lock
Abiomed, Inc.
1000457
In Commercial Distribution

  • 00813502013252 ()
1000457

  • Vascular catheter introduction set, nonimplantable
Ventricular (Assist) Bypass
Abiomed, Inc.
Cannula Kit 10mm/42 Atrial (Hem)
Not in Commercial Distribution

  • 00813502010787 ()
0506-1042-HA

  • Implantable ventricular circulatory assist system
Ventricular (Assist) Bypass
Abiomed, Inc.
Cannula Kit 12mm/32 Atrial (Sil)
Not in Commercial Distribution

  • 00813502010763 ()
0506-1232-SA

  • Implantable ventricular circulatory assist system
Ventricular (Assist) Bypass
Abiomed, Inc.
Cannula Kit 10mm/32 Apical (Hem)
Not in Commercial Distribution

  • 00813502010756 ()
0506-1032-HV

  • Implantable ventricular circulatory assist system
Ventricular (Assist) Bypass
Abiomed, Inc.
Cannula Kit 10mm/32 Atrial (Hem)
Not in Commercial Distribution

  • 00813502010749 ()
0506-1032-HA

  • Implantable ventricular circulatory assist system
Ventricular (Assist) Bypass
Abiomed, Inc.
42FR VENT/ATR CANN PKGD BOXED
Not in Commercial Distribution

  • 00813502010732 ()
0506-0042M-VA

  • Implantable ventricular circulatory assist system
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