VORTRAN GO2VENT

Primary DI
10637320000167
Brand
VORTRAN GO2VENT
Company
VORTRAN MEDICAL TECHNOLOGY 1, INC
Model
6123-16
Catalog number
6123-16
Device description
The GO2VENT provides constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for safety. The working mechanism of the GO2VENT consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient).
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTLVentilator, Emergency, Powered (Resuscitator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTLVentilator, Emergency, Powered (Resuscitator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162968000VORTRAN GO2VENTVortran Medical Technology 1, Inc.2017-04-10BTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20637320000164PackageGS110In Commercial Distribution
10637320000167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063732000016420637320000164
1063732000016710637320000167

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary resuscitator, pneumatic, single-useA non-sterile device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
916-648-8460vyang@vortran.com

Regulatory Flags#

DUNS number
090508636
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00637320061239VORTRAN GO2VENT® with Peep Valve612361232025-02-20
10637320062004VORTRAN GO2VENT with PEEP Valve620062002021-05-04
20637320062001VORTRAN GO2VENT with PEEP Valve620062002021-05-04
10637320039600VORTRAN® APM-Plus396039602020-01-30
10637320039006VORTRAN Airway Pressure MonitorAPM-3900APM-39002016-06-14
10637320060017VORTRAN GO2VENT600160012019-05-03
10637320000112VORTRAN GO2VENT 660066002019-04-19
20637320050503VAR Surgical Center KitPCK-5050PCK-50502016-07-14
20637320060014VORTRAN GO2VENT600160012019-05-03
10637320000105VORTRAN GO2VENT612361232017-06-07
10637320024507VCI (VORTRAN Cuff Inflator)245024502018-08-31
10637320040200VORTRAN-IPPBIP-4020IP-40202016-06-14
10637320040217VORTRAN-IPPB with Water TrapIPW-4021IPW-40212016-06-14
10637320040224VORTRAN-IPPB with ManomterIPM-4022IPM-40222016-06-14
10637320040309VORTRAN PercussiveNEBPNB-4030PNB-40302016-06-14
10637320050001VAR (VORTRAN Automatic Resuscitator)PT-5000PT-50002015-11-04
10637320050018VAR (VORTRAN Automatic Resuscitator) with ManometerPTM-5001PTM-50012015-11-04
10637320050025VAR (VORTRAN Automatic Resuscitator) with ExtensionPTE-5002PTE-50022015-11-04
10637320050100VAR (VORTRAN Automatic Resuscitator)PC-5010PC-50102015-11-05
10637320050117VAR (VORTRAN Automatic Resuscitator) with ManometerPCM-5011PCM-50112016-06-14

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