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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 brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090N
Not in Commercial Distribution

  • 10814321020152 ()
  • 00814321020155 ()


  • Electromagnetic blood flowmeter
The medilog®AR is used to record a 3-channel ECG. The recorder is designed for a measuring duration of more than 24 hours and is therefore worn by the patient throughout the day. The preparation for the recording (attachingelectrodes, etc.) is performed by the technician or doctor.
Schiller AG
1A.306010
In Commercial Distribution

  • 07613365003765 ()
  • 07613365003697 ()
1A.306010

  • Electrocardiographic ambulatory recorder
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-HT
In Commercial Distribution

  • M973BL06161 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-34
Not in Commercial Distribution

  • M973BH201M1 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080S
Not in Commercial Distribution

  • 00814321020186 ()


  • Electromagnetic blood flowmeter
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090S
Not in Commercial Distribution

  • 00814321020162 ()


  • Electromagnetic blood flowmeter
CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution

  • B467CSP4522575100 ()
  • B467CSP452257510016 ()
CSP3

  • Haemodialysis concentrate
The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 30709334883884 ()
  • 00709334883883 ()
RQL-100

  • Manual blood lancing device, single-use
The Disposable Safety Lancet is intended for capillary blood sampling.
Stat Medical Devices, Inc.
Qwik-Lance Safety Lancet
In Commercial Distribution

  • 40709334761882 ()
  • 00709334761884 ()
RQN-100

  • Manual blood lancing device, single-use
The identifeye Camera System is a fundus ophthalmic camera reconditioned.
Identifeye Health Inc.
850-30004-00
In Commercial Distribution

  • 00850067214281 ()


  • Ophthalmic fundus camera
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