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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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Xcela - H965750710

Xcela Power Injectable PICC (6F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
75-071
In Commercial Distribution

  • H965750710 ()
  • H965750711 ()

  • Length: 55 Centimeter
  • Catheter Gauge: 6 French
  • Pressure: 271 Pound per Square Inch
  • Needle Gauge: 21 Gauge
  • Outer Diameter: 1.94 Millimeter


  • Peripherally-inserted central venous catheter

Xcela - H965750700

Xcela Power Injectable PICC (5F x 55cm, Dual Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
75-070
In Commercial Distribution

  • H965750700 ()
  • H965750701 ()

  • Catheter Gauge: 5 French
  • Outer Diameter: 1.73 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter
  • Pressure: 233 Pound per Square Inch


  • Peripherally-inserted central venous catheter

Xcela - H965750690

Xcela Power Injectable PICC (5F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
75-069
In Commercial Distribution

  • H965750690 ()
  • H965750691 ()

  • Pressure: 236 Pound per Square Inch
  • Outer Diameter: 1.68 Millimeter
  • Needle Gauge: 21 Gauge
  • Length: 55 Centimeter
  • Catheter Gauge: 5 French


  • Peripherally-inserted central venous catheter

Xcela - H965750680

Xcela Power Injectable PICC (4F x 55cm, Single Lumen) - Maximal Barrier Dual Fenestrated Drape Nursing Kit
NAVILYST MEDICAL, INC.
75-068
In Commercial Distribution

  • H965750680 ()
  • H965750681 ()

  • Outer Diameter: 1.4 Millimeter
  • Length: 55 Centimeter
  • Pressure: 272 Pound per Square Inch
  • Catheter Gauge: 4 French
  • Needle Gauge: 21 Gauge


  • Peripherally-inserted central venous catheter

WiSE CRT System - 00859244007029

Battery
EBR Systems, Inc.
3100
In Commercial Distribution

  • 00859244007029 ()


  • Implantable pacemaker battery

Xcela - H965451840

9.6F x 500mm Xcela Plastic Dual Lumen Power Injectable Port with Pre-Attached Polyurethane Catheter and Silicone Plug
NAVILYST MEDICAL, INC.
H965451840
In Commercial Distribution

  • H965451840 ()
  • 07640110982358 ()

  • Lumen/Inner Diameter: 0.9 Millimeter
  • Length: 500 Millimeter
  • Needle Gauge: 17 Gauge
  • Catheter Gauge: 9.6 French
  • Outer Diameter: 3.2 Millimeter


  • Vascular port/catheter

Xcela - H965451830

9.6F x 500mm Xcela Plastic Dual Lumen Power Injectable Port with Attachable Polyurethane Catheter and Silicone Plug
NAVILYST MEDICAL, INC.
H965451830
In Commercial Distribution

  • H965451830 ()
  • 07640110982341 ()

  • Outer Diameter: 3.2 Millimeter
  • Lumen/Inner Diameter: 0.9 Millimeter
  • Catheter Gauge: 9.6 French
  • Length: 500 Millimeter
  • Needle Gauge: 17 Gauge


  • Vascular port/catheter

Eversense® Charging Accessories Pack - 00817491021908

Eversense® Charging Accessories Pack contains the Charging Cradle, US Configuration Power Supply and a USB Cable.
SENSEONICS, INCORPORATED
FG-6000-01-301
In Commercial Distribution

  • 00817491021908 ()
FG-6000-01-301

  • Implantable glucose monitoring system

SynCardia Freedom® Home AC Power Supply - 00858000003282

No Description
SYNCARDIA SYSTEMS, LLC
295600-001
In Commercial Distribution

  • 00858000003282 ()


  • Ventricular prosthesis system, pneumatically-powered

SynCardia Freedom® Hospital AC Power Supply - 00858000003275

No Description
SYNCARDIA SYSTEMS, LLC
295400-001
In Commercial Distribution

  • 00858000003275 ()


  • Ventricular prosthesis system, pneumatically-powered
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