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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 (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
A liquid control appropriate for immunoassay and ionic exchange HPLC methodologies. Contains 3 vials each of Level 1 and 2.
STRECK, INC.
211124
In Commercial Distribution

  • 00844509000938 ()

  • Total Volume: 2.0 Milliliter
211124

  • Glycated haemoglobin (HbA1c) IVD, control
Controls for use in the quantitative determination of human glycohemoglobin (HbA1) in blood by cation exchange resin. 2 x 1.0ml
POINTE SCIENTIFIC, INC.
G7540-2
In Commercial Distribution

  • 00811727011336 ()
G7540-2

  • Glycated haemoglobin (HbA1c) IVD, control
This product is used in medical facilityes and attached to our endoscope to prevent air leak or backflow of body fluid from the forceps inlet. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-LL2
In Commercial Distribution

  • 34547410079358 ()
  • 04547410079357 ()
  • 84547410079353 ()


  • Endoscope working-channel valve, single-use
This product is used in medical facilities and attached to the forceps inlet of endoscope to prevent leak or backflow or air. Do not use this product for any other purpose.
FUJIFILM CORPORATION
FOV-DV7
In Commercial Distribution

  • 34547410079327 ()
  • 04547410079326 ()
  • 84547410079322 ()


  • Endoscope working-channel valve, single-use
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