VENTEC LIFE SYSTEMS, INC.

Address:12350 NE Woodinville Drive,Woodinville,WA,98072,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) (8) Ventilator, Continuous, Facility Use (CBK) (8) Device, Positive Pressure Breathing, Intermittent (NHJ) (7) Generator, Oxygen, Portable (CAW) (5) Pump, Portable, Aspiration (Manual Or Powered) (BTA) (4) Filter, Bacterial, Breathing-Circuit (CAH) (2)

Premarket Exempt

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VOCSN Power Supply - 00855573007389 Catalog Number : PRT-00990-000

Device Description : VOCSN Power Supply

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

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

Prescription Use : No

Device Count : 1

VOCSN O2 Low Pressure Inlet - 00855573007396 Catalog Number : PRT-00981-000

Device Description : VOCSN O2 Low Pressure Inlet, 10-Pack

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU

Prescription Use : No

Device Count : 10

VOCSN Internal Bacterial Filter - 00855573007402 Catalog Number : PRT-00976-000

Device Description : VOCSN Internal Bacterial Filter, 10-Pack

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, NHJ, CAH

Prescription Use : No

Device Count : 10

VOCSN Patient Air Intake Filters - 00855573007419 Catalog Number : PRT-00977-000

Device Description : VOCSN Patient Air Intake Filters, 25-Pack

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK, NOU, CAW, NHJ

Prescription Use : No

Device Count : 25

VOCSN Fan Filters - 00855573007426 Catalog Number : PRT-00978-000

Device Description : VOCSN Fan Filters, 25-Pack

Device Class :

Duns Number: 078758082

Premarket Exempt : No

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

Prescription Use : No

Device Count : 25

VOCSN-VC - 00855573007433 Catalog Number : PRT-00900-001

Device Description : VOCSN-VC Pro, English: The VC configuration of VOCSN contains Vent VOCSN-VC Pro, English: The VC configuration of VOCSN contains Ventilation and Cough therapies.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 : CBK, NOU, NHJ, CAH

Prescription Use : Yes

Device Count : 1

VOCSN 24 Volt Wheelchair Power Cable - 00855573007440 Catalog Number : PRT-01027-000

Device Description : VOCSN 24 Volt Wheelchair Power Cable

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : BTA, NHJ, CAW, NOU

Prescription Use : No

Device Count : 1

VOCSN External Suction Canister Adapter - 00855573007464 Catalog Number : PRT-01030-000

Device Description : VOCSN External Suction Canister Adapter

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : BTA

Prescription Use : No

Device Count : 1

VOCSN Removable, Rechargeable Battery Set - 00855573007471 Catalog Number : PRT-00980-000

Device Description : VOCSN Removable, Rechargeable Battery Set, Lithium-ion

Device Class :

Duns Number: 078758082

Premarket Exempt : No

Product Code : NHJ, CAW, NOU, CBK

Prescription Use : No

Device Count : 2

VOCSN Removable Battery Quick Charger - 00855573007488 Catalog Number : PRT-01003-000

Device Description : VOCSN Removable Battery Quick Charger

Device Class : 2

Duns Number: 078758082

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

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