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

Continuous, Ventilator, Home Use (NOU) (5) Ventilator, Continuous, Facility Use (CBK) (5) Device, Positive Pressure Breathing, Intermittent (NHJ) (3) Generator, Oxygen, Portable (CAW) (2) Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (BZE) (2) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (1) Filter, Bacterial, Breathing-Circuit (CAH) (1)

Premarket Exempt

Clear

VOCSN Roll Stand - 00855573007907 Catalog Number : PRT-00569-001

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 - 00855573007921 Catalog Number : PRT-00795-00X

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

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : NOU, NHJ, BZE, CBK

Prescription Use : No

Device Count : 1

VOCSN - 00855573007945 Catalog Number : PRT-01201-000

Device Description : V+Pro Emergency, English: The VOCSN Unified Respiratory System is intended to pr V+Pro Emergency, 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

VOCSN Patient Air Intake Filters - 00855573007952 Catalog Number : PRT-01203-000

Device Description : VOCSN Patient Air Intake Filters, 3-Pack

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, CAW, NHJ

Prescription Use : No

Device Count : 3

VOCSN Fan Filters - 00855573007969 Catalog Number : PRT-01206-000

Device Description : VOCSN Fan Filters, 3-Pack

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

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

Prescription Use : No

Device Count : 3

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