VENTEC LIFE SYSTEMS, INC.

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

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Ventilator, Continuous, Facility Use (CBK) (9) Continuous, Ventilator, Home Use (NOU) (8) Device, Positive Pressure Breathing, Intermittent (NHJ) (7) Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (BZE) (4) Filter, Bacterial, Breathing-Circuit (CAH) (2) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (2) Generator, Oxygen, Portable (CAW) (1)

Premarket Exempt

Clear

VOCSN Nurse Call Cable - 00855573007112 Catalog Number : PRT-00821-001

Device Description : VOCSN Nurse Call Cable, Normally Open

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

VOCSN Travel Suction Canister - 00855573007129 Catalog Number : PRT-00824-001

Device Description : VOCSN Travel Suction Canister

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 1

VOCSN Humidifier Bypass - 00855573007136 Catalog Number : PRT-00832-001

Device Description : VOCSN Humidifier Bypass (Blue)Available as - 10-pack (00855573007372) - 4-Pack VOCSN Humidifier Bypass (Blue)Available as - 10-pack (00855573007372) - 4-Pack of Humidifier Bypass (00855573007136) with 4-pack of Adult, Active, Heated, Blue Circuit (00855573007921)

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : NHJ, NOU, CBK

Prescription Use : No

Device Count : 1

VOCSN Roll Stand - 00855573007174 Catalog Number : PRT-00569-000

Device Description : VOCSN Roll Stand

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : NOU, CBK

Prescription Use : No

Device Count : 1

VOCSN Patient Breathing Package - 00855573007181 Catalog Number : PRT-00927-001

Device Description : VOCSN Patient Breathing Package (Pediatric, Valveless, Blue)

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ

Prescription Use : No

Device Count : 1

VOCSN - 00855573007204 Catalog Number : PRT-00490-1XX

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 :

Duns Number: 078758082

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

VOCSN - 00855573007211 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 :

Duns Number: 078758082

Premarket Exempt : No

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

Prescription Use : Yes

Device Count : 1

VOCSN Patient Breathing Package - 00855573007228 Catalog Number : PRT-00926-001

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

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ

Prescription Use : No

Device Count : 1

VOCSN Patient Breathing Package - 00855573007235 Catalog Number : PRT-00928-001

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

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ, BZE

Prescription Use : No

Device Count : 1

VOCSN Patient Breathing Package - 00855573007341 Catalog Number : PRT-00929-001

Device Description : VOCSN Patient Breathing Package (Pediatric, Valveless, Heated, Blue)

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ, BZE

Prescription Use : No

Device Count : 1

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