Identity
- Trade Name
- VORTRAN GO2VENT® with Peep Valve FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, single-use FDA UDI
- Device Name
- The VORTRAN GO2VENT® with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above. FDA UDI
- Model / Reference
- 6123 FDA UDI
- Description
- The VORTRAN GO2VENT® with PEEP Valve is to be used by properly trained personnel to deliver emergency, short-term, constant flow, pressure-cycled ventilatory support on patients weighing 10 kg and above. FDA UDI
Identifiers
- Catalog Number
- 6123 FDA UDI
- Primary DI / UDI-DI
- 00637320061239 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® with Peep Valve 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
- 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
- VORTRAN GO2VENT — 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 810f9917-5a3e-4509-9a74-735f137909eb 36 fields · synced May 30, 2026