AccessGUDID - DEVICE: BRAEBON PT2 Dual Differntial Airflow Pressure Kit (B1400580D0)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON PT2 Dual Differntial Airflow Pressure Kit
Version or Model: 0580D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0580D
Company Name: Braebon Medical Corporation

Primary DI Number: B1400580D0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

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 1 Ultima Dual Pressure Sensor; 2 Micro Nasal Cannulae; 2 Oral + Nasal Cannulae.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, Breathing Frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K984431	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 51a75a12-ad04-4c25-bd19-316d5d92de10
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016