BiWaze Clear System

Primary DI
B965BK367
Brand
BiWaze Clear System
Company
Abmrc LLC
Model
BK181
Catalog number
BK181
Device 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
Published
2023-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NHJDevice, Positive Pressure Breathing, Intermittent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B965BK367PackageHIBCC1In Commercial Distribution
B965BK368PackageHIBCC1In Commercial Distribution
B965BK181PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
In-exsufflation/lung-oscillation airway secretion-clearing systemAn assembly of powered devices intended for use in healthcare and homecare settings to help clear airway secretions using one of two pre-configured programs: 1) mechanical insufflation-exsufflation for simulating a cough in a patient with an ineffective cough [e.g., due to neuromuscular deficits, COPD]; and 2) lung oscillation by pressurized air pulses, and lung expansion therapy by positive expiratory pressure (e.g., for prevention of pulmonary atelectasis). The system includes an electropneumatic generator/interface unit and breathing circuit elements (e.g., face mask, mouthpiece); it is also capable of delivering medicated aerosol and supplemental oxygen during therapy.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-877-226-7201customer.service@abmrc.com

Regulatory Flags#

DUNS number
033900786
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08500501360228BiWaze Clear Dual Lumen Circuit With Face Mask - InfantBK902BK9022026-05-20
08500501360235BiWaze Clear Dual Lumen Circuit - AcuteBK909BK9092026-05-20
B965BK181BiWaze Clear SystemBK181BK1812023-04-14
08500501360013BiWaze Cough Dual Lumen Circuit With MouthpieceBC23387BC233872024-04-01
08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterBC23394BC233942024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildBC23400BC234002024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallBC23406BC234062024-04-01
08500501360051BiWaze Cough Dual Lumen Circuit With Face Mask - Adult MediumBC23412BC234122024-04-01
08500501360068BiWaze Cough Dual Lumen Circuit With Face Mask - Adult LargeBC23418BC234182024-04-01
08500501360075BiWaze Clear Dual Lumen Circuit With MouthpieceBK280BK2802023-07-25
08500501360082BiWaze Clear Dual Lumen Circuit With Trach AdapterBK293BK2932023-07-25
08500501360099BiWaze Clear Dual Lumen Circuit With Face Mask - ChildBK291BK2912023-07-25
08500501360105BiWaze Clear Dual Lumen Circuit With Face Mask - Adult SmallBK289BK2892023-07-25
08500501360112BiWaze Clear Dual Lumen Circuit With Face Mask - Adult MediumBK287BK2872023-07-25
08500501360129BiWaze Clear Dual Lumen Circuit With Face Mask - Adult LargeBK285BK2852023-07-25
B9652037351818201130BiWaze Cough2037351818201132023-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500501360228BiWaze Clear Dual Lumen Circuit With Face Mask - InfantAbmrc LLCNHJ2026-05-20
08500501360235BiWaze Clear Dual Lumen Circuit - AcuteAbmrc LLCNHJ2026-05-20
00887761008038The Vest APX SystemHILL-ROM SERVICES PTE. LTD.NHJ2026-03-18
00887761008045The Vest APX SystemHILL-ROM SERVICES PTE. LTD.NHJ2026-03-18
07321822320002ClearoBreas Medical ABNHJ2026-02-17
00850018761451Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-12-02
07321820104666Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
05060405720083ClearoBreas Medical ABNHJ2025-11-03
07321820081691ClearoBreas Medical ABNHJ2025-11-03
07321820082834ClearoBreas Medical ABNHJ2025-11-03
07321820090655ClearoBreas Medical ABNHJ2025-11-03
07321820090662ClearoBreas Medical ABNHJ2025-11-03
07321820090679ClearoBreas Medical ABNHJ2025-11-03
07321820106226Clearo Patient Circuit AmericasBreas Medical ABNHJ2025-11-03
00850018761413Internal Battery PM Upgrade USB DriveVentec Life Systems, Inc.NHJ2025-08-06
08809517011064Comfort CoughSeoil Pacific Corp.NHJ2025-02-19
00850018761383VOCSN Passive ValveVentec Life Systems, Inc.NHJ2024-12-02
00849436000730PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
10849436000737PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-08-05
00849436000709PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
00849436000716PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000706PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
10849436000713PercussionairePERCUSSIONAIRE CORPORATIONNHJ2024-06-27
08500501360013BiWaze Cough Dual Lumen Circuit With MouthpieceAbmrc LLCNHJ2024-04-01
08500501360020 BiWaze Cough Dual Lumen Circuit With Trach AdapterAbmrc LLCNHJ2024-04-01
08500501360037BiWaze Cough Dual Lumen Circuit With Face Mask - ChildAbmrc LLCNHJ2024-04-01
08500501360044BiWaze Cough Dual Lumen Circuit With Face Mask - Adult SmallAbmrc LLCNHJ2024-04-01
08500501360051BiWaze Cough Dual Lumen Circuit With Face Mask - Adult MediumAbmrc LLCNHJ2024-04-01
08500501360068BiWaze Cough Dual Lumen Circuit With Face Mask - Adult LargeAbmrc LLCNHJ2024-04-01
00887761981690Volara SystemHILL-ROM SERVICES PTE. LTD.NHJ2023-11-28