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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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SSO2 Catheter - 00862478000438

The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 4.0
In Commercial Distribution

  • 20862478000432 ()
  • 00862478000438 ()
  • 10862478000435 ()

  • 5F


  • Supersaturated oxygen therapy system catheter

DownStream Cartridge - 00862478000421

The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
DSC-2
In Commercial Distribution

  • 10862478000428 ()
  • 00862478000421 ()


  • Supersaturated oxygen therapy system cartridge

DownStream System - 00862478000414

The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
DS-1
In Commercial Distribution

  • 00862478000414 ()


  • Supersaturated oxygen therapy system

DownStream System - 00862478000407

The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion
THEROX, INC.
DS-1 (Refurbished)
In Commercial Distribution

  • 00862478000407 ()


  • Supersaturated oxygen therapy system

respistim LQS Stimulation Lead, Inline Connector - 00857688007490

Respiratory stimulation lead. respistim LQS with additional proximal tubing, 85cm; quadpolar; distal bias, inline connector
RESPICARDIA, INC.
4685
In Commercial Distribution

  • 00857688007490 ()


  • Transvenous phrenic nerve electrical stimulation control unit

respistim LQS Stimulation Lead, Inline Connector - 00857688007483

Respiratory stimulation lead. respistim LQS, additional proximal tubing, 65cm; quadpolar; distal bias, inline connector
RESPICARDIA, INC.
4665
In Commercial Distribution

  • 00857688007483 ()


  • Transvenous phrenic nerve electrical stimulation control unit

respistim R Stimulation Lead, Inline Connector - 00857688007469

Respiratory stimulation lead. respistim R, 50 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias, inline connector
RESPICARDIA, INC.
3653
In Commercial Distribution

  • 00857688007469 ()


  • Transvenous phrenic nerve electrical stimulation control unit

respistim R Stimulation Lead, Inline Connector - 00857688007452

Respiratory stimulation lead; respistim R, 50cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector
RESPICARDIA, INC.
3652
In Commercial Distribution

  • 00857688007452 ()


  • Transvenous phrenic nerve electrical stimulation control unit

respistim R Stimulation Lead, Inline Connector - 00857688007445

Respiratory stimulation lead. respistim R, 60 cm; 35 mm distal spring length; 20 mm distal coil diameter; hexapolar; distal spiral bias, inline connector
RESPICARDIA, INC.
3603
In Commercial Distribution

  • 00857688007445 ()


  • Transvenous phrenic nerve electrical stimulation control unit

respistim R Stimulation Lead, Inline Connector - 00857688007438

Respiratory stimulation lead; respistim R, 60cm; 25mm distal spring length; 24 mm distal coil diameter; hexapolar; distal spiral bias, inline connector
RESPICARDIA, INC.
3602
In Commercial Distribution

  • 00857688007438 ()


  • Transvenous phrenic nerve electrical stimulation control unit
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