Identity
- Trade Name
- OxyPlus™ FDA UDI
- Generic Name
- Vortex oxygen face mask FDA UDI
- Device Name
- OxyPlus Non PVC with 7ft tubing FDA UDI
- Model / Reference
- OP-7025-8 FDA UDI
- Description
- OxyPlus Non PVC with 7ft tubing FDA UDI
Identifiers
- Catalog Number
- OP-7025-8 FDA UDI
- Primary DI / UDI-DI
- 10620974000454 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Vortex oxygen face mask FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vortex oxygen face mask
OxyPlus™ by Southmedic Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vortex oxygen face mask.
- AirLife™ — Airlife, Inc. · Class I
- AirLife™ — Airlife, Inc. · Class I
- AirLife™ — Airlife, Inc. · Class I
- OxyKid™ — Southmedic Incorporated · Class I
- OxyMask™ II — Southmedic Incorporated · Class I
- OxyMulti Kid Ultra™ — Southmedic Incorporated · Class II
- OxyKid™ — Southmedic Incorporated · Class I
- OxyMulti-Mask™ — Southmedic Incorporated · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Southmedic Incorporated
Sources (1)
- FDA UDI 4e22ae82-50ab-48c6-bd9e-a94d2e8d6dfa 35 fields · synced May 30, 2026