VOCSN - V+O+C+S+N, English: The VOCSN Unified Respiratory - VENTEC LIFE SYSTEMS, INC.

Duns Number:078758082

Device Description: V+O+C+S+N, English: The VOCSN Unified Respiratory System is intended to provide continuous 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

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More Product Details

Catalog Number

PRT-01100-0XX

Brand Name

VOCSN

Version/Model Number

V+O+C+S+N, English

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K162877,K162877

Product Code Details

Product Code

BTA

Product Code Name

Pump, Portable, Aspiration (Manual Or Powered)

Device Record Status

Public Device Record Key

a20f4fc8-e6de-41a6-9d3d-583c3eaf3d63

Public Version Date

May 29, 2020

Public Version Number

3

DI Record Publish Date

October 25, 2019

Additional Identifiers

Package DI Number

00850018761024

Quantity per Package

1

Contains DI Package

00855573007747

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"VENTEC LIFE SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 43