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BiWaze Clear System

FDA UDI

Class II (US FDA UDI)

by Abmrc LLC

Identity

Trade Name
BiWaze Clear System FDA UDI
Generic Name
In-exsufflation/lung-oscillation airway secretion-clearing system FDA UDI
Device Name
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 FDA UDI
Model / Reference
BK181 FDA UDI
Description
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 FDA UDI

Identifiers

Catalog Number
BK181 FDA UDI
Primary DI / UDI-DI
B965BK181 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 Clear System 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 d4d83d07-78f1-47b2-b743-e207142ca582 35 fields · synced Jun 8, 2026