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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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OSV II® Valve System WITH INTEGRAL 7CM VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909719
In Commercial Distribution

  • 10381780034087 ()
  • M2729097191 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 7cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909719

  • Ventriculo-peritoneal/atrial shunt
OSV II® Valve System WITH ANTECHAMBER AND INTEGRAL 7 cm VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909718
In Commercial Distribution

  • 10381780034070 ()
  • M2729097181 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 7cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909718

  • Ventriculo-peritoneal/atrial shunt
OSV II® Valve System WITH SEPARATE 15CM VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909713
In Commercial Distribution

  • 10381780034049 ()
  • M2729097131 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909713

  • Ventriculo-peritoneal/atrial shunt
OSV II® Valve System WITH ANTECHAMBER AND SEPARATE 15CM VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909712
In Commercial Distribution

  • 10381780034032 ()
  • M2729097121 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909712

  • Ventriculo-peritoneal/atrial shunt
OSV II® Lumbar Valve System
Integra LifeSciences Switzerland Sàrl
909711
In Commercial Distribution

  • 10381780034025 ()
  • M2729097111 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Lumbar Cath. 80cm Length x 1.6mm O.D. x 0.8mm I.D. (F5), 14G Tuohy Needle, F8-F5 Stepdown Connector
909711

  • Lumboperitoneal shunt
OSV II® Valve System WITH ANTECHAMBER AND INTEGRAL 9CM VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909705
In Commercial Distribution

  • 10381780033974 ()
  • M2729097051 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 9cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909705

  • Ventriculo-peritoneal/atrial shunt
OSV II® Valve System WITH ANTECHAMBER AND INTEGRAL 13CM VENTRICULAR CATHETER
Integra LifeSciences Switzerland Sàrl
909704
In Commercial Distribution

  • 10381780033967 ()
  • M2729097041 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 13cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909704

  • Ventriculo-peritoneal/atrial shunt
OSV II® Valve System 3 PIECES SYSTEM WITH ANTECHAMBER
Integra LifeSciences Switzerland Sàrl
909702
In Commercial Distribution

  • 10381780033943 ()
  • M2729097021 ()

  • Flow Regulation Valve: 18-30ml/h, Distal Cath. 110cm Length x 2.3mm O.D. x 1.1mm I.D. (F7), Vent. Cath. 15cm Length x 2.7mm O.D. x 1.4mm I.D. (F8), Right Angle Guide 4.9mm Diam.
909702

  • Ventriculo-peritoneal/atrial shunt
OSV II® Valve Unit WITH 2 INTEGRAL CONNECTORS
Integra LifeSciences Switzerland Sàrl
909701
In Commercial Distribution

  • 10381780033936 ()
  • M2729097011 ()

  • Flow Regulation Valve: 18-30ml/h
909701

  • Ventriculo-peritoneal/atrial shunt
The LungFit PH Verification Kit (p/n 90015) is used during the Verification Check procedure to check the performance of the system before the system is attached to the patient circuit. The NDM is attached between the two open lengths of 22mm tubing and the gas sample line is attached to the sample T adaptor. A full description of how it is used is included in the LungFit PH Operators Manual section 9.3 (Beyond Air p/n 20038).
Beyond Air, Inc.
90015
In Commercial Distribution

  • B882900151 ()
  • B882900150 ()
  • B882900152 ()


  • Nitric oxide delivery unit, system-based
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