Identity
- Trade Name
- VORTRAN GO2VENT FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, single-use FDA UDI
- Device Name
- The GO2VENT provides constant flow, 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 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). FDA UDI
- Model / Reference
- 6123-16 FDA UDI
- Description
- The GO2VENT provides constant flow, 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 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). FDA UDI
Identifiers
- Catalog Number
- 6123-16 FDA UDI
- Primary DI / UDI-DI
- 10637320000167 FDA UDI
- 510(k) Number
- K162968 FDA UDI
- FDA Product Code
- BTL FDA UDI
- GMDN Term
- Pulmonary resuscitator, pneumatic, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Pulmonary resuscitator, pneumatic, single-use
Vortran Go2vent by Vortran Medical Technology 1, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pulmonary resuscitator, pneumatic, single-use.
- VORTRAN GO2VENT — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- VORTRAN GO2VENT® with Peep Valve — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- E-Surge Kit — VORTRAN MEDICAL TECHNOLOGY 1, INC.
- VAR (VORTRAN Automatic Resuscitator) with Extension — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- VAR (VORTRAN Automatic Resuscitator) — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- VAR (VORTRAN Automatic Resuscitator) with Manometer — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- VORTRAN GO2VENT — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
- VAR (VORTRAN Automatic Resuscitator) — VORTRAN MEDICAL TECHNOLOGY 1, INC. · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Vortran Medical Technology 1, Inc.
Sources (1)
- FDA UDI 05e885b0-a986-4412-9021-5067670049b2 36 fields · synced May 30, 2026