VORTRAN GO2VENT
Basic Information
- Brand Name
- VORTRAN GO2VENT
- Primary DI
- 10637320060017
- Version / Model
- 6001
- Catalog Number
- 6001
- Company Name
- VORTRAN MEDICAL TECHNOLOGY 1, INC
- Labeler DUNS
- 090508636
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-03
- Public Version
- 2
- Public Version Date
- 2019-10-16
- Public Version Status
- Update
- Public Device Record Key
- 2af00251-5778-4f97-857b-c0270147968d
Device Description
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | Anesthesiology | 868.5925 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20637320060014 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 10637320060017 | GS1 |
Customer Contacts
- Phone
- (800) 434-4034
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162968 | 000 |