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BiWaze Cough

FDA UDI

Class II (US FDA UDI)

by Abmrc LLC

Identity

Trade Name
BiWaze Cough FDA UDI
Generic Name
In-exsufflation/lung-oscillation airway secretion-clearing system FDA UDI
Device Name
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 endotracheal tube 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. FDA UDI
Model / Reference
203735181820113 FDA UDI
Description
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 endotracheal tube 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. FDA UDI

Identifiers

Primary DI / UDI-DI
B9652037351818201130 FDA UDI
FDA Product Code
NHJ FDA UDI
GMDN Term
In-exsufflation/lung-oscillation airway secretion-clearing system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5905 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

BiWaze Cough by Abmrc LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as In-exsufflation/lung-oscillation airway secretion-clearing system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abmrc LLC

Sources (1)

  • FDA UDI e15bbbbc-1891-412b-a3f1-96733ab99a30 34 fields · synced May 30, 2026