VORTRAN GO2VENT 6001

GUDID 20637320060014

The GO2VENT provides constant flow, ­pressure cycled ventilatory support in ­either pressure control or ­pressure support modes. 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).

VORTRAN MEDICAL TECHNOLOGY 1, INC

Pulmonary resuscitator, pneumatic, single-use

• Primary Device ID: 20637320060014
• NIH Device Record Key: 2af00251-5778-4f97-857b-c0270147968d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VORTRAN GO2VENT
• Version Model Number: 6001
• Catalog Number: 6001
• 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

Customer Support Contacts

• Phone: (800) 434-4034
• Email: info@vortran.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10637320060017 [Primary]
GS1	20637320060014 [Package]; Contains: 10637320060017; Package: [10 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: 2019-05-13
• Device Publish Date: 2019-05-03

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