AccessGUDID - DEVICE: BiWaze Cough (B9652037351818201130)

GUDID

Device Identifier (DI) Information

Brand Name: BiWaze Cough
Version or Model: 203735181820113
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Abmrc LLC

Primary DI Number: B9652037351818201130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033900786 *Terms of Use

Device Description: This device is designed for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow, resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in hospital, institutional setting, or at home. For use on adult patients and paediatric patients 3 years old and up.

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?
64589	In-exsufflation/lung-oscillation airway secretion-clearing system	An assembly of powered devices intended for use in healthcare and homecare settings to help clear airway secretions using one of two pre-configured programs: 1) mechanical insufflation-exsufflation for simulating a cough in a patient with an ineffective cough [e.g., due to neuromuscular deficits, COPD]; and 2) lung oscillation by pressurized air pulses, and lung expansion therapy by positive expiratory pressure (e.g., for prevention of pulmonary atelectasis). The system includes an electropneumatic generator/interface unit and breathing circuit elements (e.g., face mask, mouthpiece); it is also capable of delivering medicated aerosol and supplemental oxygen during therapy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHJ	Device, Positive Pressure Breathing, Intermittent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e15bbbbc-1891-412b-a3f1-96733ab99a30
Public Version Date: January 10, 2023
Public Version Number: 1
DI Record Publish Date: January 02, 2023