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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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EV1000 - 00690103189650

EV1000 PLATFORM
Edwards Lifesciences LLC
EV1000A
In Commercial Distribution

  • 00690103189650 ()

  • MONITOR: HEIGHT: 226 MM, WIDTH: 296 MM, DEPTH: 58.6 MM, WEIGHT: 2.1 KG (4.6 LBS), DATABOX: HEIGHT: 145 MM, WIDTH: 206 MM, DEPTH: 64 MM, WEIGHT: 0.9 KG (2.0 LBS)
EV1000A

  • General-purpose multi-parameter bedside monitor
  • Patient positioning sensor

FOGARTY - 00690103043662

FOGARTY BILIARY BALLOON PROBE 5F 40CM
Edwards Lifesciences LLC
410405F
In Commercial Distribution

  • 00690103043662 ()

  • FRENCH SIZE: 5F (1.67MM), MAXIMUM LIQUID CAPACITY: 0.4ML, MAXIMUM AIR CAPACITY: 0.8ML, MAXIMUM INFLATED BALLOON DIAMETER: 8MM
410405F

  • Biliary drain

FOGARTY - 00690103043655

FOGARTY BILIARY BALLOON PROBE 6F 23CM
Edwards Lifesciences LLC
410236F
In Commercial Distribution

  • 00690103043655 ()

  • FRENCH SIZE: 6F (2.0MM), MAXIMUM LIQUID CAPACITY: 1.25ML, MAXIMUM AIR CAPACITY: 2.5ML, MAXIMUM INFLATED BALLOON DIAMETER: 13MM
410236F

  • Biliary drain

FOGARTY - 00690103043648

FOGARTY BILIARY BALLOON PROBE 5F 23CM
Edwards Lifesciences LLC
410235F
In Commercial Distribution

  • 00690103043648 ()

  • FRENCH SIZE: 5F (1.67MM), MAXIMUM LIQUID CAPACITY: 0.4ML, MAXIMUM AIR CAPACITY: 0.8ML, MAXIMUM INFLATED BALLOON DIAMETER: 8MM
410235F

  • Biliary drain

FOGARTY - 00690103043600

FOGARTY IRRIGATION CATHETER 6FR 80CM
Edwards Lifesciences LLC
220806F
In Commercial Distribution

  • 00690103043600 ()

  • USABLE LENGTH: 80CM, FRENCH SIZE: 6F (2.0MM)
220806F

  • Biliary/vascular irrigation catheter

FOGARTY - 00690103043594

FOGARTY IRRIGATION CATHETER 4F, 80CM
Edwards Lifesciences LLC
220804F
In Commercial Distribution

  • 00690103043594 ()

  • USABLE LENGTH: 80CM, FRENCH SIZE: 4F (1.33MM)
220804F

  • Biliary/vascular irrigation catheter

FOGARTY - 00690103043587

FOGARTY IRRIGATION CATHETER 10F, 23CM
Edwards Lifesciences LLC
2202310F
In Commercial Distribution

  • 00690103043587 ()

  • USABLE LENGTH: 23CM, FRENCH SIZE: 10F (3.3MM)
2202310F

  • Biliary/vascular irrigation catheter

Edwards Lifesciences Porous Vent Plug - 00690103042115

Porous Vent Plug
Edwards Lifesciences LLC
VP038
In Commercial Distribution

  • 00690103042115 ()
  • 50690103042110 ()

  • 0.952 cm (0.375") x 3.5 cm (1.25")
VP038

  • Catheter orifice occluder

Edwards Lifesciences Porous Vent Plug - 00690103042108

Porous Vent Plug
Edwards Lifesciences LLC
VP025
In Commercial Distribution

  • 00690103042108 ()
  • 50690103042103 ()

  • 0.635 cm (0.25") x 3.3 cm (1.2")
VP025

  • Catheter orifice occluder

Edwards Lifesciences Vent Caps - 00690103036206

Vent Caps
Edwards Lifesciences LLC
SPC2063
In Commercial Distribution

  • 00690103036206 ()
  • 50690103036201 ()
SPC2063

  • Catheter orifice occluder
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