VORTRAN GO2VENT 6123-EMS

GUDID 10637320000112

The GO2VENT provides constant fl ow, 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 fl ow, 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 aff ect the PIP setting by 1~3 cm-H2O. The GO2VENT will function in any position as long as the fi nal adjustments are made in a secured position (strapped or taped to the patient).

VORTRAN MEDICAL TECHNOLOGY 1, INC

Pulmonary resuscitator, pneumatic, single-use

• Primary Device ID: 10637320000112
• NIH Device Record Key: 6584d291-504a-4370-b225-01d07c101b25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VORTRAN GO2VENT
• Version Model Number: 6123-EMS
• Catalog Number: 6123-EMS
• Company DUNS: 090508636
• Company Name: VORTRAN MEDICAL TECHNOLOGY 1, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10637320000112 [Primary]
GS1	20637320000119 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162968

FDA Product Code

• BTL: Ventilator, Emergency, Powered (Resuscitator)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-29
• Device Publish Date: 2019-04-19

On-Brand Devices [VORTRAN GO2VENT ]

• 10637320000112: The GO2VENT provides constant fl ow, pressure cycled ventilatory support in either pressure cont
• 20637320060014: The GO2VENT provides constant flow, ­pressure cycled ventilatory support in ­either pressure