BiWaze Clear System BK181

GUDID B965BK367

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

Abmrc LLC

In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system In-exsufflation/lung-oscillation airway secretion-clearing system

• Primary Device ID: B965BK367
• NIH Device Record Key: d4d83d07-78f1-47b2-b743-e207142ca582
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiWaze Clear System
• Version Model Number: BK181
• Catalog Number: BK181
• Company DUNS: 033900786
• Company Name: Abmrc LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com
• Phone: +1-877-226-7201
• Email: customer.service@abmrc.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B965BK181 [Primary]
HIBCC	B965BK367 [Package]; Contains: B965BK181; Package: [1 Units]; In Commercial Distribution
HIBCC	B965BK368 [Package]; Contains: B965BK181; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• NHJ: Device, Positive Pressure Breathing, Intermittent

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-14

Devices Manufactured by Abmrc LLC

• 08500501360013 - BiWaze Cough Dual Lumen Circuit With Mouthpiece: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Mouthpiece
• 08500501360020 - BiWaze Cough Dual Lumen Circuit With Trach Adapter: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Trach Adapter
• 08500501360037 - BiWaze Cough Dual Lumen Circuit With Face Mask - Child: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Child
• 08500501360044 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small
• 08500501360051 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium
• 08500501360068 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large: 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large
• 08500501360075 - BiWaze Clear Dual Lumen Circuit With Mouthpiece: 2023-08-02 BiWaze Clear Dual Lumen Circuit With Mouthpiece
• 08500501360082 - BiWaze Clear Dual Lumen Circuit With Trach Adapter: 2023-08-02 BiWaze Clear Dual Lumen Circuit With Trach Adapter