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 IDB965BK367
NIH Device Record Keyd4d83d07-78f1-47b2-b743-e207142ca582
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiWaze Clear System
Version Model NumberBK181
Catalog NumberBK181
Company DUNS033900786
Company NameAbmrc LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com
Phone+1-877-226-7201
Emailcustomer.service@abmrc.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB965BK181 [Primary]
HIBCCB965BK367 [Package]
Contains: B965BK181
Package: [1 Units]
In Commercial Distribution
HIBCCB965BK368 [Package]
Contains: B965BK181
Package: [1 Units]
In Commercial Distribution

FDA Product Code

NHJDevice, Positive Pressure Breathing, Intermittent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-24
Device Publish Date2023-04-14

Devices Manufactured by Abmrc LLC

08500501360013 - BiWaze Cough Dual Lumen Circuit With Mouthpiece2024-04-09 BiWaze Cough Dual Lumen Circuit With Mouthpiece
08500501360020 - BiWaze Cough Dual Lumen Circuit With Trach Adapter2024-04-09 BiWaze Cough Dual Lumen Circuit With Trach Adapter
08500501360037 - BiWaze Cough Dual Lumen Circuit With Face Mask - Child2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Child
08500501360044 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small
08500501360051 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium
08500501360068 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large
08500501360075 - BiWaze Clear Dual Lumen Circuit With Mouthpiece2023-08-02 BiWaze Clear Dual Lumen Circuit With Mouthpiece
08500501360082 - BiWaze Clear Dual Lumen Circuit With Trach Adapter2023-08-02 BiWaze Clear Dual Lumen Circuit With Trach Adapter

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