FDA.reportPublic FDA data

ABMRC LLC

Matched from indexed company URL: Abmrc LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30167745283016774528ABMRC LLC1Y2026-01-01860 Blue Gentian Road Suite 200 Eagan MN US 55121

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08500501360013BiWaze Cough Dual Lumen Circuit With Mouthpiece - BC23387+1-877-226-7201customer.service@abmrc.com
08500501360020BiWaze Cough Dual Lumen Circuit With Trach Adapter - BC23394+1-877-226-7201customer.service@abmrc.com
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - Child - BC23400+1-877-226-7201customer.service@abmrc.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2621641162905923K231728BiWaze Clear SystemNHJ2024-04-08
2621641993056504K213564BiWaze Clear SystemNHJ2022-12-21
2621641265769792K191912BiWaze CoughNHJ2020-03-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NHJ32024-04-08

PMN#

GUDID#

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 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