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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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The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump/FloProbe Kit (Non-Sterile)
Not in Commercial Distribution

  • 00814321020452 ()
6000N(KIT)

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6500N
Not in Commercial Distribution

  • 00814321020445 ()
6500N

  • Cardiopulmonary bypass system centrifugal pump
The FloPump 32mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Movair, Inc.
6400N
Not in Commercial Distribution

  • 00814321020148 ()
6400N

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
1/4" FloPump (Non-Sterile)
Not in Commercial Distribution

  • 00814321020124 ()
6300N

  • Cardiopulmonary bypass system centrifugal pump
The IBC FloPump is a single-use, disposable centrifugal blood pump intended for use only with the Medtronic Bio Medicus Bio-Console to pump blood through the extracorporeal bypass circuit during open heart surgery.
Movair, Inc.
FloPump (Non-Sterile)
Not in Commercial Distribution

  • 00814321020001 ()
6000N

  • Cardiopulmonary bypass system centrifugal pump
Auryon Laser System 100-120 Vac
EXIMO MEDICAL LTD
EXM-2001-1100
In Commercial Distribution

  • 07290017590110 ()
  • 17290017590131 ()
EXM-2001-1100

  • Atherectomy laser system beam guide-catheter, peripheral
100-120 Vac Laser system For Infra Inguinal Atherectomy
EXIMO MEDICAL LTD
EXM-2001-1100
Not in Commercial Distribution

  • 17290017590056 ()
  • 07290017590059 ()


  • Atherectomy laser system beam guide-catheter, peripheral
200-240 Vac Laser system For Infra Inguinal Atherectomy
EXIMO MEDICAL LTD
EXM-2001-1000
Not in Commercial Distribution

  • 17290017590049 ()
  • 07290017590042 ()


  • Atherectomy laser system beam guide-catheter, peripheral
ADAPTER AP40AST AFFINITY CP WW 31L
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00763000301323 ()

  • Outer Diameter: 94.0 Millimeter
  • Height: 28.0 Millimeter
  • Weight: 315.0 Gram


  • Cardiopulmonary bypass system centrifugal pump
A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains one vial each of Level 1 and 2.
STRECK, INC.
211130
In Commercial Distribution

  • 00844509000945 ()

  • Total Volume: 2.0 Milliliter
211130

  • Glycated haemoglobin (HbA1c) IVD, control
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