BiWaze Cough

Basic Information

• Brand Name: BiWaze Cough
• Primary DI: B9652037351818201130
• Version / Model: 203735181820113
• Company Name: Abmrc LLC
• Labeler DUNS: 033900786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-02
• Public Version: 1
• Public Version Date: 2023-01-10
• Public Version Status: New
• Public Device Record Key: e15bbbbc-1891-412b-a3f1-96733ab99a30

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

• 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: No
• 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
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B9652037351818201130	HIBCC

Customer Contacts

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