AccessGUDID - DEVICE: BRAEBON Ultima Airflow Sensor for Alice 3 (B1400510A0)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON Ultima Airflow Sensor for Alice 3
Version or Model: 0510A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0510A
Company Name: Braebon Medical Corporation

Primary DI Number: B1400510A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: Thermistor airflow sensor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system.

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:	No
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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZQ	Monitor, Breathing Frequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K981445	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
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 32 Degrees Celsius
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: 05ef4434-a967-4fb9-8723-1026d7837374
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016