AccessGUDID - DEVICE: Vibralung Patient Kit with Circulair II Model 0295 (00709078001505)

GUDID

Device Identifier (DI) Information

Brand Name: Vibralung Patient Kit with Circulair II Model 0295
Version or Model: 9605-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078001505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: No description.

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":	Yes
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?
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?.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYI	Percussor, Powered-Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K133057	000

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
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6af31c03-16ed-4182-b5dc-12e7a749911d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2016