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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 XVIVO Organ Chamber™ is intended to be used as a temporary receptacle for isolated donor lungs in preparation for eventual transplantation into a recipient.
Xvivo Perfusion AB
19020
In Commercial Distribution

  • 07350069520074 ()
19020

  • Lung donor-organ preservation/evaluation system lung-interface set
REFORM CAPS T RING 14.5/12MM The ALCON ReFORM Capsular Tension Ring is a sterile, non-optical ocular implant, manufactured from a single piece of PMMA(POlymethylmethacrylate).
Alcon Laboratories, Inc.
8065225705
In Commercial Distribution

  • 00380652257053 ()

  • Outer diameter compressed : 12.0 Millimeter
  • Outer Diameter: 14.5 Millimeter


  • Capsular tension ring
Eversense Mobile Application (iOS) is a software application that runs on a mobile device (e.g., smartphone or tablet) and displays glucose data, trend information, and alerts.
SENSEONICS, INCORPORATED
FG-5501-02-300
In Commercial Distribution

  • 00817491023520 ()
FG-5501-02-300

  • Implantable glucose monitoring system
The Model 2403-300 Transmit Coil is a non-sterile external component that is placed within a standard sterile sleeve for use by a clinician in the operating room. The Transmit Coil is placed over the Rechargeable Neuroregulator (RNR) and attached to the Mobile Charger to provide a radio frequency link with the RNR for charging and communication.
Reshape Lifesciences Inc.
2403-300
Not in Commercial Distribution

  • 00857334004316 ()

  • Outer Diameter: 5 Inch
2403-300

  • Vagus nerve electrical stimulation system programmer
90017 is a kit containing two off-the-shelf components: - 1: (61928) 22M-22F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 22mm-diameter breathing circuit.
Beyond Air, Inc.
90017
In Commercial Distribution

  • B882900171 ()
  • B882900170 ()
  • B882900172 ()


  • Nitric oxide delivery unit, system-based
90007 is a kit containing two off-the-shelf components: - 1: (61920) 15M-15F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 15mm-diameter breathing circuit.
Beyond Air, Inc.
90007
In Commercial Distribution

  • B882900071 ()
  • B882900070 ()
  • B882900072 ()


  • Nitric oxide delivery unit, system-based
90006 is a kit containing two off-the-shelf components. - 1: (61922) 10M-10F Straight Connector with 7.6 mm Port - 2: (61921) Luer Elbow, fits 7.6 mm Port The two pieces fit together to provide a sampling port which fits on a 10mm-diameter breathing circuit.
Beyond Air, Inc.
90006
In Commercial Distribution

  • B882900061 ()
  • B882900060 ()
  • B882900062 ()


  • Nitric oxide delivery unit, system-based
The Model 1620 AC Recharger is a non-sterile external power supply that connects to a power outlet for use in charging the battery within the Mobile Charger.
Reshape Lifesciences Inc.
1620
Not in Commercial Distribution

  • 00857334004200 ()

  • Length: 9.5 Inch
1620

  • Noninvasive device battery charger
IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and 9390 A/E shipped after April 12, 2004 with 4 year full replacement guarantee.
Zoll Medical Corporation
9146-302
In Commercial Distribution

9146-302

  • Primary battery
IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and 9390 A/E shipped after April 12, 2004 with 4 year full replacement guarantee.
Cardiac Science Corporation
9146-302
In Commercial Distribution

  • 00812394020294 ()
9146-302

  • Primary battery
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