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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.
3090S
Not in Commercial Distribution

  • 00814321020162 ()


  • Electromagnetic blood flowmeter
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
BresoSensor is a component of BresoDX1. During a test, BresoSensor is placed on the suprasternal notch of a patient and collects the tracheal sound and tracheo-sternal motion through a microphone and three-dimensional accelerometer. The BresoSensor is powered by an internal Lithium-ion rechargeable battery. It is only sold in USA.
BresoTec Inc
BTSM1US-URU
In Commercial Distribution

  • 00990008600022 ()


  • Home-use sleep apnoea recording system
CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution

  • B467CSP4522575100 ()
  • B467CSP452257510016 ()
CSP3

  • Haemodialysis concentrate
SCT01 is the device for the measurement of body temperature.
YA HORNG ELECTRONIC CO., LTD.
SCT01
In Commercial Distribution

  • 04719873310067 ()
  • 14719873310064 ()


  • Intermittent electronic patient thermometer
SCT01 is the device for the measurement of body temperature.
YA HORNG ELECTRONIC CO., LTD.
SCT01
In Commercial Distribution

  • 04719873310012 ()
  • 14719873310019 ()


  • Intermittent electronic patient thermometer
The TETH-XTN-MM-8 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-8 Meter
In Commercial Distribution

  • 00850011306109 ()
31-0613-0005

  • Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-5 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-5 Meter
In Commercial Distribution

  • 00850011306093 ()
31-0613-0004

  • Electrical-only medical device connection cable, reusable
The TETH-XTN-MM-2 is a component of the ATLAS Neurophysiology System
NEURALYNX, INC.
EXTENSION CABLE: TETH-XTN-2 Meter
In Commercial Distribution

  • 00850011306086 ()
31-0613-0003

  • Electrical-only medical device connection cable, reusable
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