VORTRAN GO2VENT

Primary DI
10637320000112
Brand
VORTRAN GO2VENT
Company
VORTRAN MEDICAL TECHNOLOGY 1, INC
Model
6600
Catalog number
6600
Device description
The GO2VENT provides constant fl ow, pressure cycled ventilatory support in either pressure controlor pressure support modes on patients weighing 10kg and above. The device includes the pulmonarymodulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector teeto supply gas fl ow, entrain additional air, and provides a redundant pop-off valve for safety. Theworking mechanism of the GO2VENT consists of a moving diaphragm which adds or subtractsspring force when it is moved from a horizontal to a vertical position, the addition or subtraction ofspring force will aff ect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position aslong as the fi nal adjustments are made in a secured position (strapped or taped to the patient).
Published
2019-04-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

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
20637320000119PackageGS16In Commercial Distribution
10637320000112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2063732000011920637320000119
1063732000011210637320000112

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.

Sterilization Methods#

Method table
Method

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
20637320050503VAR Surgical Center KitPCK-5050PCK-50502016-07-14
20637320060014VORTRAN GO2VENT600160012019-05-03
10637320000105VORTRAN GO2VENT612361232017-06-07
10637320000167VORTRAN GO2VENT6123-166123-162017-06-07
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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