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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StarClose SE™ Vascular Closure System
ABBOTT VASCULAR INC.
14679-01
In Commercial Distribution

  • 28717648079461 ()
  • 08717648079467 ()
14679-01

  • Implantable vascular closure clip
LungFit PH Product Description The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line. The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
Beyond Air, Inc.
90002
In Commercial Distribution

  • B882900020 ()


  • Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80013
In Commercial Distribution

  • B882800130 ()


  • Nitric oxide delivery unit, system-based
Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line.
Beyond Air, Inc.
80012
In Commercial Distribution

  • B882800120 ()


  • Nitric oxide delivery unit, system-based
CARTRIDGE, STAMPED (ETO STERILE SGL)
ANIMAS CORPORATION
10012402
Not in Commercial Distribution

  • 10840406100129 ()
  • 10840406100136 ()
  • 10840406100174 ()
10012402

  • Ambulatory insulin infusion pump, electronic, software-dosing, scalar algorithm
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Morcher GmbH
20C RIGHT V.1
In Commercial Distribution

  • 04048509620004 ()


  • Capsular tension ring
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Morcher GmbH
14 LEFT V.3
In Commercial Distribution

  • 04048509392109 ()


  • Capsular tension ring
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Morcher GmbH
14A LEFT V.1
In Commercial Distribution

  • 04048509392093 ()


  • Capsular tension ring
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Morcher GmbH
14C LEFT V.3
In Commercial Distribution

  • 04048509392086 ()


  • Capsular tension ring
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Morcher GmbH
15B RIGHT V.1
In Commercial Distribution

  • 04048509392079 ()


  • Capsular tension ring
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