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Vocsn

FDA UDI

Class II (US FDA UDI)

by Ventec Life Systems, Inc.

Identity

Trade Name
VOCSN FDA UDI
Generic Name
Emergency airway clearance suction system, electric FDA UDI
Device Name
VOCSN 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 FDA UDI
Model / Reference
VOCSN, English FDA UDI
Description
VOCSN 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 FDA UDI

Identifiers

Catalog Number
PRT-00490-001 FDA UDI
Primary DI / UDI-DI
00855573007006 FDA UDI
510(k) Number
K162877 FDA UDI
FDA Product Code
CAH FDA UDI
BZE FDA UDI
BTA FDA UDI
NHJ FDA UDI
CAW FDA UDI
NOU FDA UDI
CBK FDA UDI
GMDN Term
Emergency airway clearance suction system, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5260 FDA UDI
868.5270 FDA UDI
878.4780 FDA UDI
868.5905 FDA UDI
868.5440 FDA UDI
868.5895 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Portable electric ventilatorMobile/portable oxygen concentratorEmergency airway clearance suction system, electricIn-exsufflator

Vocsn by Ventec Life Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as In-exsufflator.

Cleared under the same submission

K162877 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ventec Life Systems, Inc.

Sources (1)

  • FDA UDI 08662a63-a921-4db8-9bf8-a6f9617da394 36 fields · synced May 30, 2026