DEVICE: VORTRAN GO2VENT (10637320000112)
Device Identifier (DI) Information
VORTRAN GO2VENT
6600
In Commercial Distribution
6600
VORTRAN MEDICAL TECHNOLOGY 1, INC
6600
In Commercial Distribution
6600
VORTRAN MEDICAL TECHNOLOGY 1, INC
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).
Device Characteristics
| MR Conditional | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 57981 | Pulmonary resuscitator, pneumatic, single-use |
A 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.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K162968 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
6584d291-504a-4370-b225-01d07c101b25
October 16, 2019
2
April 19, 2019
October 16, 2019
2
April 19, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| 20637320000119 | 6 | 10637320000112 | In Commercial Distribution |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined