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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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HydroMax, Disposable, Heat and Moisture Exchange Filter
A-M SYSTEMS, LLC
HydroMax - 158200
In Commercial Distribution

  • 00817081020502 ()
  • 00817081020496 ()
158200

  • Heat/moisture exchanger/microbial medical gas filter
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033579
In Commercial Distribution

  • 30801902001376 ()
  • 00801902001375 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033577
In Commercial Distribution

  • 30801902001369 ()
  • 00801902001368 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033580
In Commercial Distribution

  • 30801902101526 ()
  • 00801902101525 ()
RC-09850

  • Vascular catheter introduction set, nonimplantable
RIC(R) Rapid Infusion Catheter Exchange Set
TELEFLEX INCORPORATED
IPN033578
In Commercial Distribution

  • 30801902101519 ()
  • 00801902101518 ()
RC-09700

  • Vascular catheter introduction set, nonimplantable
Xper Flex Cardio 2020 Rev D Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev D Exchange
In Commercial Distribution

  • 00884838086012 ()
453564675001

  • General-purpose multi-parameter bedside monitor
Xper Flex Cardio 2020 Rev E Exchange
Philips Ds North America LLC
Xper Flex Cardio 2020 Rev E Exchange
Not in Commercial Distribution

  • 00884838093782 ()
453564845861

  • General-purpose multi-parameter bedside monitor
For Therapeutic Plasma Exchange (TPE) Procedure. For Red Blood Cell Exchange (RBCX) Procedures. For Use with the AMICUS Separator. Sterile Fluid Path.
Fresenius Kabi AG
X6R2349
In Commercial Distribution

  • 04086000101950 ()
  • 14086000101957 ()
X6R2349

  • Therapeutic plasma/red blood cell exchange tubing set
No Description
Merit Medical Systems, Inc.
00884450239476
In Commercial Distribution

  • 10884450239473 ()
  • 00884450239476 ()
  • 20884450239470 ()

  • Tip Shape-3 mm J-Tip
  • Length-260 cm (102")
  • Configuration-Amplatz Exchange
  • Length-260 cm (102"); Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
  • Configuration-Amplatz Exchange; Tip Shape-3 mm J-Tip; Length-260 cm (102"); Configuration-Amplatz Exchange
IQA502

  • Cardiac/peripheral vascular guidewire, single-use
BladderScan® Prime Plus™ Probe, Probe Exchange
VERATHON INC
Prime Plus™
In Commercial Distribution

  • 10879123008012 ()
  • 00879123008015 ()
E570-0395

  • Bladder ultrasound imaging transducer
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