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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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BAND SIM SC 800SC28 SEMI-RIGID
MEDTRONIC, INC.
800SC28
In Commercial Distribution

  • 00643169182189 ()

  • Lumen/Inner Diameter: 28.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
BAND SIM SC 800SC30 SEMI-RIGID
MEDTRONIC, INC.
800SC30
In Commercial Distribution

  • 00643169182172 ()

  • Lumen/Inner Diameter: 30.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
BAND SIM SC 800SC32 SEMI-RIGID
MEDTRONIC, INC.
800SC32
In Commercial Distribution

  • 00643169182165 ()

  • Lumen/Inner Diameter: 32.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
BAND SIM SC 800SC34 SEMI-RIGID
MEDTRONIC, INC.
800SC34
In Commercial Distribution

  • 00643169182158 ()

  • Lumen/Inner Diameter: 34.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
BAND SIM SC 800SC36 SEMI-RIGID
MEDTRONIC, INC.
800SC36
In Commercial Distribution

  • 00643169182141 ()

  • Lumen/Inner Diameter: 36.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
BAND SIM SC 800SC38 SEMI-RIGID
MEDTRONIC, INC.
800SC38
In Commercial Distribution

  • 00643169182134 ()

  • Lumen/Inner Diameter: 38.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
BAND SIM SC 800SC40 SEMI-RIGID
MEDTRONIC, INC.
800SC40
In Commercial Distribution

  • 00643169182127 ()

  • Lumen/Inner Diameter: 40.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
RING SIM SR 800SR24 SEMI-RIGID
MEDTRONIC, INC.
800SR24
In Commercial Distribution

  • 00643169182110 ()

  • Lumen/Inner Diameter: 24.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
RING SIM SR 800SR26 SEMI-RIGID
MEDTRONIC, INC.
800SR26
In Commercial Distribution

  • 00643169182103 ()

  • Lumen/Inner Diameter: 26.0 Millimeter


  • Mitral/tricuspid annuloplasty ring, open-surgery
Balloon Catheter 6225 Attain Clarity
MEDTRONIC, INC.
6225
Not in Commercial Distribution

  • 00643169181717 ()

  • Minimum guide catheter inner diameter 1.9 mm (5.7 Fr)
  • Nominal balloon diameter 13 mm
  • Catheter usable length 90 cm
  • Maximum guidewire diameter 0.018 in (0.46 mm)
  • Nominal inflation volume 2.5 ml
  • Maximum inflation volume 2.75 ml


  • Cardiac ventriculography catheter
CUSTOM PACK CB6J79R1 E ADAPTR
MEDTRONIC, INC.
CB6J79R1
Not in Commercial Distribution

  • 00643169181632 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL1119R5 SUPP VENT
MEDTRONIC, INC.
TL1119R5
In Commercial Distribution

  • 00643169181397 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 7N28R 12PK C02
MEDTRONIC, INC.
7N28R
In Commercial Distribution

  • 20643169181148 ()
  • 00643169181144 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7L48R1 PERF EPUMP HD
MEDTRONIC, INC.
CB7L48R1
In Commercial Distribution

  • 00643169181021 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 5G81R5 3/8 E. PK
MEDTRONIC, INC.
5G81R5
Not in Commercial Distribution

  • 00643169181014 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB7N55R 20PK 3/8 DBL L
MEDTRONIC, INC.
CB7N55R
In Commercial Distribution

  • 20643169180974 ()
  • 00643169180970 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7L71R1 P N T 2
MEDTRONIC, INC.
TL7L71R1
Not in Commercial Distribution

  • 00643169180963 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 0H30R21
MEDTRONIC, INC.
0H30R21
Not in Commercial Distribution

  • 00643169178847 ()


  • Cardiopulmonary bypass system blood tubing set
CONSOLE 31363 ACTTRAC CE IVDD
MEDTRONIC, INC.
31363
In Commercial Distribution

  • 00643169178434 ()


  • Multiple coagulation factor IVD, control
INSTRUMENT ACT200 ACT PLUS 220VN1 IVDD
MEDTRONIC, INC.
ACT200
Not in Commercial Distribution

  • 00643169178410 ()


  • Coagulation timer IVD
INSTRUMENT ACT100 ACT PLUS 110V IVDD
MEDTRONIC, INC.
ACT100
In Commercial Distribution

  • 00643169178380 ()


  • Coagulation timer IVD
OXYGENATOR BB811 FUSION W/BALANCE
MEDTRONIC, INC.
BB811
In Commercial Distribution

  • 00643169178168 ()


  • Extracorporeal membrane oxygenator
OXY/CVR COMBO BB841 FUSION W/BALANCE
MEDTRONIC, INC.
BB841
In Commercial Distribution

  • 00643169178144 ()


  • Extracorporeal membrane oxygenator
FILTER BB851 AF100 WITH BALANCE
MEDTRONIC, INC.
BB851
In Commercial Distribution

  • 20643169178124 ()
  • 00643169178120 ()


  • Cardiopulmonary bypass system filter, arterial blood line
OXYGENATOR CB811 FUSION W/CARMEDA
MEDTRONIC, INC.
CB811
In Commercial Distribution

  • 00643169178090 ()


  • Extracorporeal membrane oxygenator
FILTER CB851 AF100 WITH CARMEDA
MEDTRONIC, INC.
CB851
Not in Commercial Distribution

  • 20643169178032 ()
  • 00643169178038 ()


  • Cardiopulmonary bypass system filter, arterial blood line
CUSTOM PACK 1A63R11 E INFANT
MEDTRONIC, INC.
1A63R11
Not in Commercial Distribution

  • 00643169178014 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK 1A64R10 PEDI E
MEDTRONIC, INC.
1A64R10
Not in Commercial Distribution

  • 00643169178007 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK CB5R04R5 E SUPPORT
MEDTRONIC, INC.
CB5R04R5
In Commercial Distribution

  • 00643169177581 ()


  • Cardiopulmonary bypass system blood tubing set
CUSTOM PACK TL7M96R1 HEART L 2
MEDTRONIC, INC.
TL7M96R1
Not in Commercial Distribution

  • 00643169177130 ()


  • Cardiopulmonary bypass system blood tubing set
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