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Sign in to claim this brandSouthmedic Incorporated
US
Last updated May 24, 2026
What Southmedic Incorporated makes
Southmedic Incorporated manufactures single-use and reusable medical devices, including vortex oxygen face masks like the OxyPlus™ and OxyMask™, which are designed for respiratory support. Their portfolio also covers disposable items such as face splash shields, scalpel blades, and skin-closing tension devices, alongside reusable surgical instrument cleaning brushes and endoscope cleaning utensils. Breathing circuit gas-sampling and monitoring sets, such as the Capnoxygen®, are also part of their offerings, alongside medical device cleaning agents.
The company’s devices are classified under FDA categories including Class I, Class II, and Class III, with all products listed in the FDA’s Unique Device Identifier (UDI) database. Southmedic Incorporated is based in the United States, adhering to regulatory requirements applicable to medical devices in that jurisdiction.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Southmedic Incorporated manufacture?
Southmedic Incorporated manufactures single-use and reusable medical devices, including vortex oxygen face masks like the OxyPlus™ and OxyMask™, disposable items such as face splash shields and scalpel blades, reusable surgical instrument cleaning brushes and endoscope cleaning utensils, breathing circuit gas-sampling and monitoring sets like the Capnoxygen®, and medical device cleaning agents.
Where is Southmedic Incorporated based?
Southmedic Incorporated is based in the United States, as indicated by the COUNTRY field in the device data, and operates under the regulatory requirements applicable to medical devices in that jurisdiction.
In which regulatory registry are Southmedic Incorporated's devices listed?
Southmedic Incorporated's devices are listed in the FDA's Unique Device Identifier (UDI) database, as specified in the LISTED IN field, which confirms their inclusion in the UDI system for device traceability and identification.
How are Southmedic Incorporated's devices classified?
Southmedic Incorporated's devices are classified under FDA categories including Class I, Class II, and Class III, as stated in the DEVICE CLASSES field, reflecting a range of risk-based classifications across their product portfolio.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- southmedic.com
- —
- —
- [email protected]
- Phone
- +1(705)726-9383
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 246848147
Catalogue (302)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Capnoxygen® | CO2-01 | FDA UDI | Class II | Active |
| Dynamic Tissue Systems™ | CWK-EX | FDA UDI | Class II | Active |
| OxyTyke™ | OT-1025-8 | FDA UDI | Class I | Active |
| Sterile Stainless Blades | 73-0020 | FDA UDI | Class I | Active |
| Southmedic Instrument Cleaning Brushes | PK45909 | FDA UDI | Class I | Active |
| Southmedic Instrument Cleaning Brushes | PK45606 | FDA UDI | Class I | Active |
| Dynamic Tissue Systems™ | DCX10 | FDA UDI | Class I | Active |
| OxyMask™ II | OT-1025-8 | FDA UDI | Class I | Active |
| Dynamic Tissue Systems™ | CWK-3 | FDA UDI | Class I | Active |
| EcoZyme Auto | 17560-05 | FDA UDI | Class I | Active |
| SPSS Disposable Scalpels | 73-9021 | FDA UDI | Class I | Active |
| OxyMask™ | OKN-1025 | FDA UDI | Class II | Active |
| OxyMask™ | OPN-1025 | FDA UDI | Class II | Unknown |
| Southmedic Instrument Cleaning Brushes | PK45552 | FDA UDI | Class I | Active |
| Bite Block | ETPSR-00P50 | FDA UDI | Class I | Active |
| Capnoxygen® | CO2-04-14 | FDA UDI | Class II | Unknown |
| Dynamic Tissue Systems™ | DCX20 | FDA UDI | Class I | Active |
| Southmedic Instrument Cleaning Brushes | PKM16SS | FDA UDI | Class I | Active |
| Dynamic Tissue Systems™ | CWM02A | FDA UDI | Class II | Active |
| BetterShield™ | MXFS-100 | FDA UDI | Class I | Active |
| OxyMask™ Aerosol | OMN-1025 | FDA UDI | Class II | Active |
| OxyPlus™ | OP-2325-8 | FDA UDI | Class II | Unknown |
| EcoZyme Ultra | 18560-2.5 | FDA UDI | Class I | Active |
| OxyMulti Kid Ultra™ | OKHH-1425-8 | FDA UDI | Class II | Unknown |
| Southmedic Instrument Cleaning Brushes | PK45911 | FDA UDI | Class I | Active |
| Dynamic Tissue Systems™ | DCNE-02 | FDA UDI | Class I | Active |
| Vapofil™ | 8907-E | FDA UDI | Class II | Unknown |
| Southmedic Instrument Cleaning Brushes | PK45553 | FDA UDI | Class I | Active |
| Capnoxygen® | CO2-01-14 | FDA UDI | Class II | Unknown |
| OxyMulti-Mask™ | OPMK-4025-8 | FDA UDI | Class II | Active |
| Southmedic Instrument Cleaning Brushes | PK45912 | FDA UDI | Class I | Active |
| Capnoxygen® | CO2-11 | FDA UDI | Class II | Unknown |
| SPSS Cartridges | 73-8023 | FDA UDI | Class I | Unknown |
| OxyMask™ II | OK-2125-8 | FDA UDI | Class II | Active |
| Oxy2Pro | PRM-2110-8F | FDA UDI | Class II | Active |
| Dynamic Tissue Systems™ | CWK-H | FDA UDI | Class II | Active |
| Capnoxygen® | CO2-04-SLM | FDA UDI | Class II | Active |
| Southmedic Instrument Cleaning Brushes | PK45908 | FDA UDI | Class I | Active |
| SPSS Disposable Scalpels | 73-9015 | FDA UDI | Class I | Active |
| Clear Choice | SMI9214B | FDA UDI | Class I | Active |
| Oxy2Mask O2/EtCO2 | OP-2125-8SLM | FDA UDI | Class II | Active |
| OxyPlus™ | OP-7025-8 | FDA UDI | Class I | Active |
| Oxy2Mask O2/EtCO2 | OM-2125-14 | FDA UDI | Class II | Active |
| Cabo | 73-7016 | FDA UDI | Class I | Unknown |
| OxyMask™ II | OM-1125-8 | FDA UDI | Class I | Active |
| Disposable Safety Scalpel | 73-0210R | FDA UDI | Class I | Active |
| Disposable Scalpel | 73-0121 | FDA UDI | Class I | Active |
| Sterile Stainless Blades | 73-0011 | FDA UDI | Class I | Active |
| OxyMask™ | OM-1125-8 | FDA UDI | Class I | Active |
| Dynamic Tissue Systems™ | SWC01 | FDA UDI | Class I | Active |
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