AccessGUDID - DEVICE: AEROBIKA OPEP with Manometer (62860110504023)

GUDID

Device Identifier (DI) Information

Brand Name: AEROBIKA OPEP with Manometer
Version or Model: 110504
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 11050494010
Company Name: Trudell Medical International

Primary DI Number: 62860110504023
Issuing Agency: GS1
Commercial Distribution End Date: April 22, 2020
Device Count: 10
Labeler D-U-N-S® Number*: 203298203 *Terms of Use

Device Description: AEROBIKA OPEP with Manometer (package of 10)

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?
43947	Positive pressure airway secretion-clearing device	A hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BWF	Spirometer, Therapeutic (Incentive)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150173	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55d9c3bd-4298-4650-90e1-ea2f191253e3
Public Version Date: June 22, 2021
Public Version Number: 6
DI Record Publish Date: September 24, 2016