ABMRC LLC

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• abmrc.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• BiWaze Clear System

  2024-04-08

  Abmrc, LLC

• BiWaze Clear System

  2022-12-21

  Abmrc, LLC

• BiWaze Cough

  2020-03-27

  ABMRC LLC

GUDID#

• BiWaze Clear Dual Lumen Circuit With Face Mask - Infant - BK902

  Abmrc LLC

  2026-05-20

• BiWaze Clear Dual Lumen Circuit - Acute - BK909

  Abmrc LLC

  2026-05-20

• BiWaze Clear System - The BiWaze Clear System is indicated for the loosening and mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and can provide supplemental oxygen when used with an oxygen supply. The BiWaze Clear System is for use on adult or pediatric patients in acute care (aged 2 years and older) and home care environments (aged 5 years and older).The BiWaze Clear System may be used with patient interfaces including face mask, mouthpiece, a trach adapter to endotracheal or tracheostomy tube in acute and home care environments. The BiWaze Clear System may be used in-line with a ventilator in acute care environment only.

  Abmrc LLC

  2023-04-14

• BiWaze Cough Dual Lumen Circuit With Mouthpiece - BC23387

  Abmrc LLC

  2024-04-01

• BiWaze Cough Dual Lumen Circuit With Trach Adapter - BC23394

  Abmrc LLC

  2024-04-01

• BiWaze Cough Dual Lumen Circuit With Face Mask - Child - BC23400

  Abmrc LLC

  2024-04-01

• BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small - BC23406

  Abmrc LLC

  2024-04-01

• BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium - BC23412

  Abmrc LLC

  2024-04-01

• BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large - BC23418

  Abmrc LLC

  2024-04-01

• BiWaze Clear Dual Lumen Circuit With Mouthpiece - BK280

  Abmrc LLC

  2023-07-25

• BiWaze Clear Dual Lumen Circuit With Trach Adapter - BK293

  Abmrc LLC

  2023-07-25

• BiWaze Clear Dual Lumen Circuit With Face Mask - Child - BK291

  Abmrc LLC

  2023-07-25

• BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Small - BK289

  Abmrc LLC

  2023-07-25

• BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Medium - BK287

  Abmrc LLC

  2023-07-25

• BiWaze Clear Dual Lumen Circuit With Face Mask - Adult Large - BK285

  Abmrc LLC

  2023-07-25

• BiWaze Clear System - 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

  2023-04-14

• BiWaze Cough - 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 endotrachealtube 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.

  Abmrc LLC

  2023-01-02