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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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Acumen IQ Sensor with Vamp with TruWave - 00690103205831

ACUMEN IQ SENSOR 60'' / 152CM WITH FLUID METER WITH VAMP WITH TRUWAVE 5-PACK
Edwards Lifesciences LLC
AIQSFM6C502
In Commercial Distribution

  • 50690103205836 ()
  • 00690103205831 ()
AIQSFM6C502

  • Intravenous line sensor, gravity infusion

Diacap® - 04039239090496

Diacap® Ultra Dialysis Fluid Filters
B.Braun Avitum AG
7107367
Not in Commercial Distribution

  • 04039239090496 ()
  • 04039239090489 ()
7107367

  • Haemodialysis system dialysate pyrogen filter

3D Side Fire Endocavity Probe - 03665134000844

Compact PERINE Probe. Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00-2
In Commercial Distribution

  • 03665134000851 ()
  • 03665134000844 ()
K3DEL00-2

  • General-purpose ultrasound imaging system

2D Linear Probe - 03665134000103

Surface 2D probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, small organs, soft tissues, urology and vascular applications Frequencies: 7-15MHz Field of view 40 mm
KOELIS
K2DLN00
In Commercial Distribution

  • 03665134000530 ()
  • 03665134000103 ()


  • General-purpose ultrasound imaging system

2D Abdominal Probe - 03665134000097

Surface 2D probe (Convex) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam for Abdominal, Gynecology, Musculoskeletal, soft tissues, Urology and Vascular applications Frequencies: 2-5MHz Field of view 460° Radius 60 mm
KOELIS
K2DAB00
In Commercial Distribution

  • 03665134000523 ()
  • 03665134000097 ()


  • General-purpose ultrasound imaging system

3D Side-Fire Endocavity Probe - 03665134000080

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology application. Frequencies: 4-9 MHz Field of view 72 mm Scanning angle 170°
KOELIS
K3DEL00
In Commercial Distribution

  • 03665134000516 ()
  • 03665134000080 ()


  • General-purpose ultrasound imaging system

3D End-Fire Endocavity Probe - 03665134000073

Invasive 2D/3D endocavity probe (linear) to be used with TRINITY ultrasound system KURO-3000-X This probe is used for 2D exam, 3D mapping, for urology and gynecology applications. Frequencies: 4-9 MHz Field of view 146° Scanning angle 90° Radius 10 mm
KOELIS
K3DEC00-2
In Commercial Distribution

  • 03665134000509 ()
  • 03665134000073 ()


  • General-purpose ultrasound imaging system

TactiSys™ - 07640157990316

Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer

TactiSys™ - 07640157990194

Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer

Diacap® - 04046963178116

DIACAP ULTRA DF FILTER CA & US
B.Braun Avitum AG
7107368
In Commercial Distribution

  • 04046963178109 ()
  • 04046963178116 ()
7107368

  • Haemodialysis system dialysate pyrogen filter
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