VENTEC LIFE SYSTEMS, INC.

Address:22002 26th Ave SE,Bothell,WA,98021,US

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- Catalog Number : PRT-01098-0XX

Device Description : V+C, English: The VOCSN Unified Respiratory System is intended to provide contin V+C, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ, BZE, CAH

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-01100-0XX

Device Description : V+O+C+S+N, English: The VOCSN Unified Respiratory System is intended to provide V+O+C+S+N, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, CAW, NHJ, BTA, BZE, CAH

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-00490-100

Device Description : V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to pro V+O+C+S+N+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CAH, BZE, BTA, NHJ, CAW, NOU, CBK

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-00900-0XX

Device Description : V+C+Pro, English: The VOCSN Unified Respiratory System is intended to provide co V+C+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CAH, BZE, NHJ, NOU, CBK

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-00900-100

Device Description : V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide c V+C+Pro, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CAH, BZE, NHJ, NOU, CBK

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-00490-0XX

Device Description : V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to prov V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral oxygen concentrator is intended for the administration of supplemental oxygen. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CAH, BZE, BTA, NHJ, CAW, NOU, CBK

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-01143-000

Device Description : The VOCSN Carry Bag supports everyday mobility with an included shoulder strap a The VOCSN Carry Bag supports everyday mobility with an included shoulder strap and attachment points for securing VOCSN to a wheelchair, bed rail, and other mounts. The Carry Bag is compatible with the VOCSN Roll Stand, the Travel Suction Canister, and other accessories. It also allows access to both removable, rechargeable batteries during use.

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

- Catalog Number : PRT-01184-0XX

Device Description : V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to prov V+O+C+S+N+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral suction pump is intended for airway fluid removal and oral/ pharyngeal hygiene. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CAH, BZE, NHJ, NOU, CBK, BTA

Prescription Use : Yes

Device Count : 1

- Catalog Number : PRT-01185-000

Device Description : V+Pro, English: The VOCSN Unified Respiratory System is intended to provide cont V+Pro, English: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. www.VentecLife.com

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CAH, BZE, NOU, CBK

Prescription Use : Yes

Device Count : 1

Device Description : VOCSN Patient Breathing Package (Adult, Active, Blue)

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ

Prescription Use : No

Device Count : 1