BRAEBON Ultima Esophageal Pressure Transducer

Basic Information

• Brand Name: BRAEBON Ultima Esophageal Pressure Transducer
• Primary DI: B1400585PESXA0
• Version / Model: 0580PES
• Catalog Number: 0580PES
• Company Name: Braebon Medical Corporation
• Labeler DUNS: 251731105
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-05
• Public Version: 1
• Public Version Date: 2024-01-15
• Public Version Status: New
• Public Device Record Key: 4391c7b3-ab66-4898-ac59-7403e282bb68

Device Description

Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Ultima Dual Pressure Sensor; 2 Dual Pressure Sensor Safety Filter + Adapter; 2 Micro Cannulae; 2 Oral + Nasal Cannulae.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
31278	Air/gas pressure transducer	A noninvasive electronic device designed to convert air or gas pressure signals into electrical signals for subsequent display or processing by a parent device (e.g., physiological data recorder, gastrointestinal motility analysis system). It may be a compact unit or included in an electrical cable, and receives pressure signals from connected pressure-measuring devices (e.g., urodynamic air-charged catheter, monitoring respiratory tubing).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1400585PESXA0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984431	000

Storage Conditions

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