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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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VALVEVAULTâ„¢ DEVICE KIT This kit includes one (1) each non-sterile, reusable VALVEVAULTâ„¢ DEVICE (S), (M), (L), all of which have Direct Marking.
LSI Solutions, Inc.
081040
In Commercial Distribution

  • 00850012846086 ()

  • (S) Chambers - Diameter: 19, 21 mm; Depth: 11.5, 12.5 mm (M) Chambers - Diameter: 23, 25 mm; Depth: 13.5, 14.5 mm (L) Chambers - Diameter: 27, 29 mm; Depth: 15.5, 16.2 mm
081040

  • Heart valve prosthesis holder, reusable
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-40
In Commercial Distribution

  • 00837654070956 ()
  • 00850012832546 ()
  • 00850012832553 ()

  • Total Volume: 40 Milliliter
  • Catheter Gauge: 7 French


  • Intra-aortic balloon catheter
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-35
In Commercial Distribution

  • 00837654076415 ()
  • 00850012832515 ()
  • 00850012832522 ()

  • Total Volume: 35 Milliliter
  • Catheter Gauge: 7 French


  • Intra-aortic balloon catheter
The Insightra Intra Aortic Balloon Catheter Kit is used in conjunction with an intra-aortic balloon pumping circuit for the emergency treatment of patients in cardiogenic shock. This condition occurs in patients post acute myocardial infarction, or with reduced cardiac output post open-heart surgery.
INSIGHTRA MEDICAL, INC.
IMU7F-30
In Commercial Distribution

  • 00837654076439 ()
  • 00850012832485 ()
  • 00850012832492 ()

  • Catheter Gauge: 7 French
  • Total Volume: 30 Milliliter


  • Intra-aortic balloon catheter
PROG-004 Kit (US)
Avertix Medical Inc.
0217-2100-004#P18
In Commercial Distribution

  • 00850012625162 ()
0217-2100-004#P18

  • Implantable cardiac device management application software
PROG-003 Carrying Case
Avertix Medical Inc.
0204-2100-079#P10
In Commercial Distribution

  • 00850012625148 ()
0204-2100-079#P10

  • Implantable cardiac device management application software
PROG-003 Application User's Manual CD
Avertix Medical Inc.
0204-2100-073#P16
In Commercial Distribution

  • 00850012625131 ()
0204-2100-073#P16

  • Implantable cardiac device management application software
PROG-003 USB Flash Drive
Avertix Medical Inc.
0204-2100-077#P10
In Commercial Distribution

  • 00850012625124 ()
0204-2100-077#P10

  • Implantable cardiac device management application software
PROG-003 External Power Accessories Kit (US)
Avertix Medical Inc.
0204-2100-093#P10
In Commercial Distribution

  • 00850012625100 ()
0204-2100-093#P10

  • Implantable cardiac device management application software
PROG-003 Serial Cable (10 foot)
Avertix Medical Inc.
0204-2100-112
In Commercial Distribution

  • 00850012625094 ()
0204-2100-112

  • Implantable cardiac device management application software
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