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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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3100A HFOV - 50190752155457

Flexible Patient Circuit, 3100A 380-90 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771463
In Commercial Distribution

  • 50190752155457 ()
771463

  • Ventilator breathing circuit, single-use

3100A HFOV - 50190752155433

Flexible Patient Circuit, 3100A, MR730 in Non-Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771375
In Commercial Distribution

  • 50190752155433 ()
771375

  • Ventilator breathing circuit, single-use

Cordella Sensor Delivery Kit - 00850008997006

The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System. Cordella PA Sensor The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex. Delivery System The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
Endotronix, Inc.
100303-05
In Commercial Distribution

  • 00850008997006 ()


  • Implantable pulmonary artery pressure monitoring system

LungFit PH - B882900020

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

3100A HFOV - 50190752159769

Flexible Patient Circuit, 3100A 380-88/ 400-00 in Non-Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
29028-007
Not in Commercial Distribution

  • 50190752159769 ()
29028-007

  • Ventilator breathing circuit, single-use

3100A HFOV - 50190752159752

Flexible Patient Circuit, 3100A 380-88/400-00 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
29028-006
Not in Commercial Distribution

  • 50190752159752 ()
29028-006

  • Ventilator breathing circuit, single-use

3100A HFOV - 50190752155464

Flexible Patient Circuit, 3100A 380-88/400-00 in Heated Environment (Box of 4)
VYAIRE MEDICAL, INC.
771465
In Commercial Distribution

  • 50190752155464 ()
771465

  • Ventilator breathing circuit, single-use

TRUFILL - 10886704029151

Contents:one 1 g tube n-BCA with self-piercing luer cap one 1 g vial Ta Powder one 10 mL vial Ethiodized Oil
Cerenovus, Inc.
631-500
In Commercial Distribution

  • 10886704029151 ()
631500

  • Neurovascular embolization plug

TRUFILL - 10886704029144

Contents:two 1 g tubes n-BCA with self-piercing luer cap one 1 g vial Ta Powder one 10 mL vial Ethiodized Oil
Cerenovus, Inc.
631-400
In Commercial Distribution

  • 10886704029144 ()
631400

  • Neurovascular embolization plug

TRUFILL - 10886704085324

TRUFILL n-BCA Liquid Embolic System Procedural Set Contents: (2) 1 g n-BCA, self-piercing caps, 1 g Ta Powder, 10 mL Ethiodized Oil, (3) 1 mL and (3) 3 mL syringes, 30 mL beaker, 18 G blunt fill needle, (2) 21 G hypodermic needles, syringe labels
Cerenovus, Inc.
632400NA
In Commercial Distribution

  • 10886704085324 ()
632400NA

  • Neurovascular embolization plug
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