FDA.reportPublic FDA data

VOCSN

Primary DI
00855573007860
Brand
VOCSN
Company
Ventec Life Systems, Inc.
Model
V+C+S+N+Pro, English
Catalog number
PRT-01184-0XX
Device description
V+O+C+S+N+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 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
Published
2020-07-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BTAPump, Portable, Aspiration (Manual Or Powered)
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
CAHFilter, Bacterial, Breathing-Circuit
CBKVentilator, Continuous, Facility Use
NHJDevice, Positive Pressure Breathing, Intermittent
NOUContinuous, Ventilator, Home Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTAPump, Portable, Aspiration (Manual Or Powered)General, Plastic Surgery2
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2
CAHFilter, Bacterial, Breathing-CircuitAnesthesiology2
CBKVentilator, Continuous, Facility UseAnesthesiology2
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2
NOUContinuous, Ventilator, Home UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162877000VOCSN Unified Respiratory SystemVentec Life Systems, Inc.2017-04-07CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855573007846PackageGS11In Commercial Distribution
00855573007860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855573007846008555730078468555730078460855573007846
00855573007860008555730078608555730078600855573007860

GMDN Terms#

Term, Definition table
TermDefinition
In-exsufflatorA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal110 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078758082
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018761048VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-00X2020-10-07
00850018761062VOCSN Patient Breathing PackageAdult, Active, Heated, Oxygen, BluePRT-00798-00X2020-10-07
00850018761116VOCSNV+C, JapanesePRT-01098-1XX2021-02-23
00855573007013VOCSN External Bacterial FilterPRT-00790-001PRT-00790-0032017-11-11
00855573007037VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-0012017-11-11
00855573007044VOCSN Patient Breathing PackageAdult, Passive, Oxygen, BluePRT-00793-0012017-11-11
00855573007075VOCSN Patient Breathing PackageAdult, Passive, BluePRT-00792-0012019-01-30
00855573007082VOCSN Patient Breathing PackageAdult, Active, Heated, BluePRT-00795-0012019-01-30
00855573007099VOCSN Patient Breathing Package Adult, Passive, Heated, BluePRT-00796-0012019-01-30
00855573007105VOCSN Nurse Call CableNormally ClosedPRT-00820-0012017-11-11
00855573007112VOCSN Nurse Call CableNormally OpenPRT-00821-0012017-11-11
00855573007129VOCSN Travel Suction CanisterPRT-00824-000PRT-00824-0012017-11-11
00855573007181VOCSN Patient Breathing PackagePediatric, Valveless, BluePRT-00927-0012019-01-30
00855573007228VOCSN Patient Breathing PackageAdult, Valveless, BluePRT-00926-0012019-01-30
00855573007235VOCSN Patient Breathing PackageAdult, Valveless, Heated, BluePRT-00928-0012019-01-30
00855573007341VOCSN Patient Breathing PackagePediatric, Valveless, Heated, BluePRT-00929-0012019-01-30
00855573007549VOCSN Patient Breathing PackagePediatric, Active, BluePRT-00799-0012018-07-10
00855573007563VOCSN Patient Breathing PackagePediatric, Active, Heated, BluePRT-00803-0012018-07-11
00855573007587VOCSN Patient Breathing PackagePediatric, Active, Oxygen, BluePRT-00802-0012018-07-11
00855573007600VOCSN Patient Breathing PackagePediatric, Active, Heated, Oxygen, BluePRT-00806-0012018-07-11

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