Identity
- Trade Name
- VAR Surgical Center Kit FDA UDI
- Generic Name
- Pulmonary resuscitator, pneumatic, single-use FDA UDI
- Device Name
- Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung FDA UDI
- Model / Reference
- PCK-5050 FDA UDI
- Description
- Kit Contains: 3 each GO2VENT Model 6123; 1 each Oxygen Regulator; 1 each Training CD; 1 each Test Lung FDA UDI
Identifiers
- Catalog Number
- PCK-5050 FDA UDI
- Primary DI / UDI-DI
- 20637320050503 FDA UDI
- GMDN Term
- Pulmonary resuscitator, pneumatic, single-use FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pulmonary resuscitator, pneumatic, single-use
VAR Surgical Center Kit by Vortran Medical Technology 1, Inc. — 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
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vortran Medical Technology 1, Inc.
Sources (1)
- FDA UDI bc83ae77-e008-45fe-b9ff-9981ce7cbf4c 35 fields · synced Jun 6, 2026