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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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SWAN-GANZ VIP+ - 00690103151756

SWAN-GANZ VIP+ TRI-LUMEN INFUSION THERMODILUTION CATHETER
Edwards Lifesciences LLC
834F75
In Commercial Distribution

  • 00690103151756 ()
  • 50690103151751 ()

  • USABLE LENGTH: 110CM, EXTERIOR DIAMETER: 7.5F (2.5MM), MINIMUM INTRODUCER SIZE: 8.5F (2.8MM), RECOMMENDED GUIDEWIRE SIZE: 0.025 IN (0.64MM)
834F75

  • Pulmonary artery balloon catheter, electrical

Edwards Lifesciences Retrograde Cardioplegia Catheter - 00690103151725

Retrograde Cardioplegia Catheter
Edwards Lifesciences LLC
ISP3073
In Commercial Distribution

  • 00690103151725 ()
  • 50690103151720 ()

  • 14 Fr. (4.7 mm) x 32 cm (12.5")
ISP3073

  • Coronary sinus cannula

Edwards Lifesciences Retrograde Cardioplegia Catheter - 00690103151374

Retrograde Cardioplegia Catheter
Edwards Lifesciences LLC
ISP3071
In Commercial Distribution

  • 00690103151374 ()
  • 50690103151379 ()

  • 14 Fr. (4.7 mm) x 27 cm (10.6")
ISP3071

  • Coronary sinus cannula

Edwards Lifesciences Dispersion Aortic Perfusion Cannula - 00690103151206

Aortic Perfusion Cannula
Edwards Lifesciences LLC
DCT24A
In Commercial Distribution

  • 00690103151206 ()
  • 50690103151201 ()

  • 24 Fr. (8.0 mm) x 30.5 cm (12")
DCT24A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Edwards Lifesciences Dispersion Aortic Perfusion Cannula - 00690103151190

Aortic Perfusion Cannula
Edwards Lifesciences LLC
DCT21A
In Commercial Distribution

  • 00690103151190 ()
  • 50690103151195 ()

  • 21 Fr. (7.0 mm) x 30.5 cm (12")
DCT21A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Edwards Lifesciences Aortic Perfusion Cannula - 00690103151022

Aortic Perfusion Cannula
Edwards Lifesciences LLC
MTS020A
Not in Commercial Distribution

  • 00690103151022 ()

  • 20 Fr. (6.7 mm) x 20 cm (8")
MTS020A

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, return

Thin-Flex Single Stage Malleable Venous Drainage Cannula - 00690103150858

Single Stage Venous Return Cannula
Edwards Lifesciences LLC
TFM032L
Not in Commercial Distribution

  • 00690103150858 ()
  • 50690103150853 ()

  • 32 Fr. (10.7 mm) x 40 cm (16")
TFM032L

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

Thin-Flex Single Stage Malleable Venous Drainage Cannula - 00690103150841

Single Stage Venous Return Cannula
Edwards Lifesciences LLC
TFM024L
Not in Commercial Distribution

  • 00690103150841 ()
  • 50690103150846 ()

  • 24 Fr. (8.0 mm) x 35 cm (14")
TFM024L

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage

SWAN-GANZ - 00690103150438

SWAN-GANZ BIPOLAR PACING CATHETER
Edwards Lifesciences LLC
D97130F5
In Commercial Distribution

  • 00690103150438 ()

  • Exterior Diameter: 5F (1.67 mm), Usable Length: 90 cm, Minimum Introducer Size: 6F (2.0mm)
D97130F5

  • Temporary cardiac pacing balloon catheter

SWAN-GANZ - 00690103150421

SWAN-GANZ BIPOLAR PACING CATHETER
Edwards Lifesciences LLC
D97120F5
In Commercial Distribution

  • 00690103150421 ()

  • Exterior Diameter: 5F (1.67 mm), Usable Length: 90 cm, Minimum Introducer Size: 6F (2.0mm)
D97120F5

  • Temporary cardiac pacing balloon catheter
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