Vibralung Patient Kit with Circulair II Model 0295

Basic Information

• Brand Name: Vibralung Patient Kit with Circulair II Model 0295
• Primary DI: 00709078001505
• Version / Model: 9605-10
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6af31c03-16ed-4182-b5dc-12e7a749911d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYI	Percussor, Powered-Electric	Anesthesiology	868.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37475	Pneumatic chest percussor	A hand-held pneumatic device designed to provide external vibrations to the chest wall of a patient (child to adult) to loosen excessive airway secretions [mucus or sputum (phlegm)] to promote airway clearance and improve bronchial drainage for patients with respiratory disease [e.g., cystic fibrosis (CF), neuromuscular disease, bronchitis, bronchiectasis, chronic obstructive pulmonary disease (COPD)]. It consists of a pneumatic valve with connecting hose that is connected to a medical facility's gas supply; it typically requires a gas pressure of 3.5 bar (50 psi). It is intended to be operated by a healthcare professional and is often referred to as a ?hand-held hammer?.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10709078001502	GS1		1	In Commercial Distribution
Primary	00709078001505	GS1

Premarket Submissions

Submission Number	Supplement Number
K133057	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 93 Percent (%) Relative Humidity