AccessGUDID - DEVICE: BiWaze Clear System (B965BK181)

GUDID

Device Identifier (DI) Information

Brand Name: BiWaze Clear System
Version or Model: BK181
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BK181
Company Name: Abmrc LLC

Primary DI Number: B965BK181
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033900786 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
64589	In-exsufflation/lung-oscillation airway secretion-clearing system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHJ	Device, Positive Pressure Breathing, Intermittent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d4d83d07-78f1-47b2-b743-e207142ca582
Public Version Date: April 24, 2023
Public Version Number: 1
DI Record Publish Date: April 14, 2023