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Sign in to claim this brandCUTTING EDGE HC BRANDS LLC
US
Last updated May 24, 2026
What CUTTING EDGE HC BRANDS LLC makes
The company manufactures single-use and reusable respiratory and feeding devices, including gastrostomy tubes for nutritional support, secretion suction kits for airway clearance, and breathing circuit connectors for ventilator use. It also produces oxygen administration tubing, suction catheters, suction/irrigation tubing, medicine chamber spacers for inhalers, and heat/moisture exchangers to maintain airway humidity during ventilation.
The portfolio includes devices classified as Class I and Class II under FDA regulations, all of which are listed in the FDA’s Unique Device Identification (UDI) database. The company operates from the United States, adhering to applicable U.S. medical device compliance requirements.
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 Cutting Edge HC Brands LLC manufacture?
Cutting Edge HC Brands LLC specializes in respiratory and feeding devices. Their portfolio includes single-use and reusable products like gastrostomy tubes for nutritional support, secretion suction kits for clearing airways, and breathing circuit connectors for ventilators. They also produce oxygen administration tubing, suction catheters, suction/irrigation tubing, inhaler spacers, and heat/moisture exchangers to maintain airway moisture during ventilation. These devices are designed for clinical use in patient care settings.
Where is Cutting Edge HC Brands LLC based?
The company is based in the United States. As a U.S.-based manufacturer, their devices are subject to U.S. medical device regulations, including compliance with FDA requirements for safety, performance, and quality.
Which regulatory registries list devices manufactured by Cutting Edge HC Brands LLC?
Devices produced by Cutting Edge HC Brands LLC are listed in the FDA’s Unique Device Identification (UDI) database. This registry helps track and identify medical devices by assigning a unique identifier to each product, ensuring transparency and traceability in the healthcare system.
How are the devices made by Cutting Edge HC Brands LLC classified under FDA regulations?
The company’s devices fall into two primary classification categories under FDA regulations: Class I and Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and benefits.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- respiratorytg.com
- —
- —
- [email protected]
- Phone
- 9999999999
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 080216804
Catalogue (111)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| O2-Life™ | RTG-05000 | FDA UDI | Class I | Active |
| RespVent™ | RTG-01051 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02114 | FDA UDI | Class I | Active |
| O2-Life™ | RTG-06004 | FDA UDI | Class II | Active |
| O2-Life™ | RTG-04000 | FDA UDI | Class I | Active |
| Nebu-Life | RTG-07101 | FDA UDI | Class II | Active |
| RespVent™ | RTG-01003 | FDA UDI | Class I | Active |
| RespVac™ | RTG-03008 | FDA UDI | Class II | Active |
| Sovea™ | ITG-41610 | FDA UDI | Class II | Active |
| Sovea™ | ITG-32420 | FDA UDI | Class II | Active |
| RespVac™ | RTG-03020 | FDA UDI | Class II | Active |
| O2-Life™ | RTG-06002 | FDA UDI | Class II | Active |
| Trach O-Life | RTG-04016 | FDA UDI | Class I | Active |
| RespVent™ | RTG-01000 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02012 | FDA UDI | Class I | Active |
| RespVac™ | RTG-03005 | FDA UDI | Class II | Active |
| O2-Life™ | RTG-04012 | FDA UDI | Class I | Active |
| RespVac™ | RTG-03004 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02118 | FDA UDI | Class I | Active |
| RespVent™ | RTG-02300 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02410 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02414 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02106 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02218 | FDA UDI | Class I | Active |
| RespVac™ | RTG-03006 | FDA UDI | Class II | Unknown |
| O2-Life™ | RTG-06006 | FDA UDI | Class II | Active |
| Sovea™ | ITG-31410 | FDA UDI | Class II | Active |
| RespVac™ | RTG-03023 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02210 | FDA UDI | Class I | Active |
| RespVent™ | RTG-01101 | FDA UDI | Class II | Active |
| O2-Life™ | RTG-06001 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02416 | FDA UDI | Class I | Active |
| O2-Life™ | RTG-06005 | FDA UDI | Class II | Active |
| Sovea™ | ITG-31210 | FDA UDI | Class II | Active |
| O2-Life™ | RTG-06007 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02008 | FDA UDI | Class I | Active |
| Sovea™ | ITG-32010 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02010 | FDA UDI | Class I | Active |
| RespVent™ | RTG-01004 | FDA UDI | Class I | Active |
| Adapt O-Life | RTG-07201 | FDA UDI | Class I | Active |
| RespVent™ | RTG-24TT14 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02110 | FDA UDI | Class I | Active |
| O2-Life™ | RTG-06000 | FDA UDI | Class II | Active |
| Trach O-Flex™ | RTG-19001 | FDA UDI | Class I | Active |
| Sovea™ | ITG-24024 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02412 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02214 | FDA UDI | Class I | Active |
| Sovea™ | ITG-23112 | FDA UDI | Class II | Active |
| RespVac™ | RTG-02408 | FDA UDI | Class I | Active |
| RespVac™ | RTG-02116 | FDA UDI | Class I | Active |
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