The CapnoFlow Oral Airway features an integrated oxygen‑delivery channel and continuous capnography port, providing airway support while enabling real‑time CO₂ monitoring. Its soft‑curve design maintains airway patency during sedation, while the reinforced bite block protects both the patient and equipment. CapnoFlow adjusts between 8cm, 9cm and 10cm. Each airway is made from smooth, medical‑grade materials designed for single‑patient use.
Shelf Life: 1‑year shelf life (use until expiration).
The CapnoFlow™ Oral Airway is intended to help maintain an open oral airway in patients requiring airway support during anesthesia, procedural sedation, or emergency care. The device facilitates supplemental oxygen delivery, capnographic monitoring and access for oropharyngeal suctioning.
The CapnoFlow™ Oral Airway is a single use, adjustable oropharyngeal airway designed to maintain a patient airway and support monitoring during procedures requiring basic airway management. Unique integrated features include:
Do not use CapnoFlow in the following situations (consistent with Guedel/Berman airway contraindications):
Conscious or semi‑conscious patients with an intact gag reflex
Active oral trauma, including broken teeth or recent oral surgery
Suspected foreign‑body airway obstruction
Known hypersensitivity to device materials
If a gag reflex, coughing, or retching occurs at any time, remove the device immediately.
Improper placement may worsen airway obstruction by pushing the tongue posteriorly.
Use only on patients who are unresponsive and unable to maintain their own airway.
Do not tape or secure the airway in a way that prevents expulsion if the patient begins to gag.
Monitor continuously for airway patency, ventilation adequacy, and oxygen saturation.
If the patient begins to regain consciousness, remove the device promptly to avoid vomiting or aspiration.
Single‑patient use only. Do not re‑use or re‑sterilize.
Select the correct size using standard OPA sizing methods (corner of mouth → angle of jaw).
Inspect the oral cavity for loose teeth, debris, or secretions before insertion.
Lubrication may be used per facility protocol.
Use caution in patients with suspected cervical spine injury—maintain neutral alignment.
Ensure the flange rests securely on the lips; do not force insertion.
Suction secretions as needed through the integrated channel to reduce aspiration risk.
Adverse events associated with oral airways—including Guedel, Berman, and CapnoFlow—may include:
Oral or dental trauma
Laryngospasm
Gagging, vomiting, or aspiration
Hypoxia due to malposition or obstruction
Bleeding or mucosal injury
Allergic reaction to device materials
Store in a cool, dry place, away from direct sunlight.
Do not use if the packaging is opened, damaged, or expired.
Dispose of used devices in accordance with local regulations for contaminated medical waste.
Provide:
CapnoFlow is available exclusively through our authorized distribution partners. To ensure product authenticity, proper handling, and reliable delivery, please place all orders directly with one of the distributors listed below.
Southeast Region
Distributor Name
Serving: FL, GA, SC, NC, AL, MS, TN
Phone: XXX‑XXX‑XXXX
Email: orders@[distributor].com
Website: www.[distributor].com
Minimum order quantities may apply depending on region
Lead times vary by distributor
Contract pricing available for IDNs, ASC groups, and GPO‑aligned facilities
All distributors carry the full CapnoFlow size range
Use high-quality graphics that show:
Make sure visuals do not imply unapproved uses.
CapnoFlow is manufactured and distributed in accordance with all applicable medical‑device quality, safety, and performance standards. Our processes, materials, and documentation follow the same regulatory expectations applied to traditional Guedel and Berman oral airways, with additional controls for integrated oxygen and CO₂‑monitoring pathways.
CapnoFlow is produced under a certified quality system aligned with:
ISO 13485: Medical Devices – Quality Management Systems
ISO 14971: Application of Risk Management to Medical Devices
ISO 10993: Biocompatibility Evaluation of Medical Devices
Good Manufacturing Practices (GMP) applicable to medical devices
All manufacturing partners undergo routine audits to ensure ongoing compliance.
All patient‑contacting materials meet the requirements of:
ISO 10993‑1 biocompatibility testing
Cytotoxicity, sensitization, and irritation standards
Latex‑free and DEHP‑free material specifications
CapnoFlow is intended for single‑patient use and is not reusable or re‑sterilizable.
Each device includes:
Lot number and manufacturing date
UDI‑compliant labeling (where required)
Clear size identification
Instructions for use (IFU) aligned with global airway‑management standards
Traceability is maintained from raw materials through final distribution.
CapnoFlow meets or exceeds:
RoHS (Restriction of Hazardous Substances)
REACH requirements for chemical safety
Local regulations for disposal of contaminated medical waste
Packaging is designed to minimize environmental impact while protecting device integrity.
For facilities, distributors, and regulatory bodies, the following documents can be provided:
Declaration of Conformity (DoC)
ISO 13485 certification
Biocompatibility summary
Risk‑management summary
Material safety information
Sterilization/cleanliness documentation (if applicable to your SKU)
Airway is classified as a Class I device under 21 CFR 868.5110, Product Code CAE (Oropharyngeal Airway), and is 510(k) exempt. Oropharyngeal airways have been 510(k) exempt since 1996.
