DEVICE: VOCSN (00855573007211)
Device Identifier (DI) Information
VOCSN
V+C+Pro, Japanese
In Commercial Distribution
PRT-00900-100
VENTEC LIFE SYSTEMS, INC.
V+C+Pro, Japanese
In Commercial Distribution
PRT-00900-100
VENTEC LIFE SYSTEMS, INC.
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 Characteristics
MR Unsafe | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36998 | In-exsufflator |
A portable, pneumatic, device that, through a rapid shift in pressure via a face mask, produces a high expiratory flow rate from the lungs, simulating a cough. This technique is referred to as EWNP (exsufflation with negative pressure) or mechanical insufflation-exsufflation. This device is suitable for any patient with an ineffective cough due to, e.g., muscular disorders or paralysis and would typically be used to clear retained broncho-pulmonary secretions, reducing the risk of respiratory complications.
|
Active | false |
47083 | Portable electric ventilator |
A portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAH | Filter, Bacterial, Breathing-Circuit |
BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
NHJ | Device, Positive Pressure Breathing, Intermittent |
NOU | Continuous, Ventilator, Home Use |
CBK | Ventilator, Continuous, Facility Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K162877 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 50 and 110 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7fea6633-6705-49e5-bedb-4be39d063f27
May 29, 2020
2
October 25, 2019
May 29, 2020
2
October 25, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00850018761000 | 1 | 00855573007211 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined