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Braebon Medical Corp.

US

Last updated May 24, 2026

Part of Braebon Medical Corporation

What Braebon Medical Corp. makes

Braebon Medical Corp. manufactures single-use and reusable respiratory tubing for gas sampling and monitoring, including nasal and oro-nasal cannulas with integrated filters. Their portfolio also includes reusable electrical connection cables, polysomnographs, pneumographs, electrocardiographic lead sets, and air/gas pressure transducers. Additionally, they produce mandible-repositioning orthoses for sleep-disordered breathing and reusable general-purpose patient temperature probes.

The company’s devices are regulated under FDA Class I and Class II classifications, with submissions recorded in the FDA 510(k) and UDI registries. Products are listed in the US, where Braebon Medical Corp. is based.

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 Braebon Medical Corp. manufacture?

Braebon Medical Corp. specializes in respiratory and monitoring devices. Their portfolio includes single-use gas-sampling/monitoring respiratory tubing like nasal and oro-nasal cannulas with built-in filters, reusable electrical connection cables, polysomnographs (sleep study equipment), pneumographs (chest movement monitors), electrocardiographic lead sets, and air/gas pressure transducers. They also produce mandible-repositioning orthoses for sleep-disordered breathing and reusable temperature probes. These devices are designed for respiratory care, sleep diagnostics, and patient monitoring.

Where is Braebon Medical Corp. based, and where are their devices regulated?

Braebon Medical Corp. is based in the United States. Their devices are regulated under FDA classifications, specifically Class I and Class II, depending on the product’s risk level. Since the company operates in the US, its devices fall under US regulatory frameworks, including submissions recorded in the FDA 510(k) and Unique Device Identifier (UDI) registries.

Which regulatory registries list Braebon Medical Corp.’s devices?

Braebon Medical Corp.’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track submissions for medical devices to ensure compliance with US regulatory requirements. The 510(k) process is used for devices deemed substantially equivalent to existing approved products, while the UDI system helps identify devices throughout their lifecycle.

How are Braebon Medical Corp.’s devices classified under FDA regulations?

Braebon Medical Corp.’s devices are classified under FDA’s risk-based system as either Class I or Class II. Class I devices generally pose minimal risk and may require only general controls, such as good manufacturing practices. Class II devices involve a higher level of risk and require special controls beyond general controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and complexity, as outlined in the FDA’s regulatory framework.

What kinds of reusable and single-use devices does Braebon Medical Corp. produce?

Braebon Medical Corp. manufactures both single-use and reusable devices. Single-use items include gas-sampling/monitoring respiratory tubing like nasal cannulas with filters (e.g., *ValueFlow Nasal Cannula + Filter*), which are designed for one-time use to prevent cross-contamination. Reusable devices in their portfolio include electrical connection cables (e.g., *BRAEBON 1 mm Dual Safety Pin to 2.5 mm Male Phone Connector Cable*), electrocardiographic lead sets, pneumographs, and temperature probes, which are built for durability and repeated use with proper sterilization or maintenance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
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Website
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LinkedIn
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Email
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Catalogue (104)

Page 2 of 3
DeviceModel / ReferenceRegistriesClassStatus
MediByte Patient Kit 8119-5
FDA UDI
Class IActive
Ultima Oral + Nasal Cannula + Filter 8589-50
FDA UDI
Class IActive
BRAEBON cTherm Cannula Thermistor for Alice 3 0514A3
FDA UDI
Class IIActive
SnoreByte Kit 3520-5
FDA UDI
Class IIActive
BRAEBON PT2 Dual Differntial Airflow Pressure Kit 0580D
FDA UDI
Class IIActive
Divided Nasall Cannula + Filter, Pediatric BM5598-50
FDA UDI
Class IActive
MediByte Patient Kit 8120-25
FDA UDI
Class IActive
Ultima Nasal Cannula, Pediatric 8582PED-50
FDA UDI
Class IActive
BRAEBON Ultima Body Position Sensor 0531
FDA UDI
Class IIUnknown
PureFlow Duo Cannula 0588-50
FDA UDI
Class IActive
BRAEBON Ultima PVDF Respiratory Effort Sensor for Alice 3 0528A
FDA UDI
Class IIActive
PureFlow OroNasal Cannula 0596-50
FDA UDI
Class IActive
SnoreByte Express 3530
FDA UDI
Class IIActive
BRAEBON MediByte MP8KLite
FDA UDI
Class IIActive
Ultima Oral + Nasal Cannula + Filter 0589-50
FDA UDI
Class IActive
BRAEBON Disposable RIP Belt, Large 5576-24
FDA UDI
Class IIActive
ValueFlow Oral + Nasal Cannula + Filter 5589-22
FDA UDI
Class IActive
BRAEBON Ultima Body Position Sensor for Alice 5 0533
FDA UDI
Class IIActive
BRAEBON cTherm Cannula Thermistor for Alice 4 0514A4
FDA UDI
Class IIActive
BRAEBON SpO2 Cable for MediByte, Small Soft Shell 8895
FDA UDI
Class IIActive
BRAEBON EKG Eliminator 0600
FDA UDI
Class IIActive
Ultima Divided Nasal Cannula + Filter 0582CO2-50
FDA UDI
Class IActive
BRAEBON MediOX MD-O
FDA UDI
Class IIActive
MediByte Patient Kit 8110-25
FDA UDI
Class IActive
BRAEBON MediByte MP8-WN
FDA UDI
Class IIActive
BRAEBON Pressure Sensor-NOX 0580-NOX
FDA UDI
Class IIActive
MediByte Patient Kit 8111-25
FDA UDI
Class IActive
BRAEBON MediByte MP8
FDA UDI
Class IIActive
Snap Electrodes, 60" 8621-60
FDA UDI
Class IIActive
BRAEBON Disposable RIP Belt, Large 5573-24
FDA UDI
Class IIActive
Snap Electrodes, 120" 8621-120
FDA UDI
Class IIActive
SnoreByte Kit 3520-5
FDA UDI
Class IIActive
PureFlow OroNasal Cannula + Filter 0597-50
FDA UDI
Class IActive
BRAEBON 1 mm Dual Safety Pin to RJ11 Connector Cable 0357
FDA UDI
Class IIActive
Paper Tape 0305-50
FDA UDI
Class IActive
PureFlow OroNasal Cannula + Filter 8597-50
FDA UDI
Class IActive
Ultima Nasal Cannula + Filter, Pediatric 0582PED-50
FDA UDI
Class IActive
OroNasal Cannula + Filter, Pediatric BM5591-25
FDA UDI
Class IActive
BRAEBON PT1 Low Gain/ Hi Pressure Transducer Kit for Alice 0580A
FDA UDI
Class IIActive
Ultima Nasal Cannula 8581-50
FDA UDI
Class IActive
BRAEBON Ultima Esophageal Pressure Transducer 0580PES
FDA UDI
Class IIActive
BRAEBON Ultima Body Position Sensor 0532
FDA UDI
Class IIActive
BRAEBON Interface Strap 0584
FDA UDI
Class IIActive
BRAEBON 1 mm Dual Safety Pin to 2.5 mm Female Phone Connector Cable 0356
FDA UDI
Class IIActive
SnoreByte Tray 3519-5
FDA UDI
Class IIActive
BRAEBON Communication Cable for MediByte 8889.21
FDA UDI
Class IIActive
BRAEBON Male Snap to Female Safety Pin Adapter 0359
FDA UDI
Class IIActive
BRAEBON Ultima Airflow Sensor for Alice 4 0510A4
FDA UDI
Class IIActive
Ultima Airflow Pressure Sensor K984431
FDA 510(k)
Class IIActive
Ultima Respiratory Effort Sensor Models 0520 And 0522 K982216
FDA 510(k)
Class IIActive

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