BiWaze Clear System

Basic Information

• Brand Name: BiWaze Clear System
• Primary DI: B965BK181
• Version / Model: BK181
• Catalog Number: BK181
• Company Name: Abmrc LLC
• Labeler DUNS: 033900786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-14
• Public Version: 1
• Public Version Date: 2023-04-24
• Public Version Status: New
• Public Device Record Key: d4d83d07-78f1-47b2-b743-e207142ca582

Device Description

The BiWaze Clear System assists patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high frequency oscillation therapies. The BiWaze Clear System may be used with a patient interface like face mask, mouthpiece, a trach adapter to a patient’s endotracheal or tracheostomy tube. It is for use on adult or paediatric patients in acute, post-acute, and home care environments. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 2 years in the acute care setting. The BiWaze Clear System is indicated to deliver therapy to adults and children over the age of 5 years in the home care setting

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
Package	B965BK367	HIBCC		1	In Commercial Distribution
Primary	B965BK181	HIBCC
Package	B965BK368	HIBCC		1	In Commercial Distribution

Customer Contacts

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