BRAEBON cTherm Cannula Thermistor for MediByte with Lemo

Basic Information

• Brand Name: BRAEBON cTherm Cannula Thermistor for MediByte with Lemo
• Primary DI: B1408514L0
• Version / Model: 8514L
• Catalog Number: 8514L
• Company Name: Braebon Medical Corporation
• Labeler DUNS: 251731105
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-14
• Public Version: 1
• Public Version Date: 2023-02-22
• Public Version Status: New
• Public Device Record Key: 5c6d3dbe-fb61-4b0e-9eca-9c757d854a90

Device Description

Cannula thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for use with MediByte.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZQ	Monitor, Breathing Frequency	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37340	General-purpose patient temperature probe, reusable	A temperature sensing device intended to be placed into a body orifice or on the body surface and used in conjunction with a separate parent device with a display (e.g., electronic patient thermometer, infant warmer) to enable measurement/monitoring of a patient’s temperature; its use is not dedicated to a specific type of procedure. It is typically constructed of flexible materials (e.g., plastic or rubber) with a metal conducting core; the distal end of different device types will be designed for a particular application site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1408514L0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K981445	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 5 – 32 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity