AEROBIKA OPEP with Manometer 11050494010

GUDID 62860110504023

AEROBIKA OPEP with Manometer (package of 10)

Trudell Medical International

Mechanical positive pressure airway secretion-clearing device

• Primary Device ID: 62860110504023
• NIH Device Record Key: 55d9c3bd-4298-4650-90e1-ea2f191253e3
• Commercial Distribution Discontinuation: 2020-04-22
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AEROBIKA OPEP with Manometer
• Version Model Number: 110504
• Catalog Number: 11050494010
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com
• Phone: 1-519-455-4862
• Email: customerservice@trudellmed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	62860110504016 [Unit of Use]
GS1	62860110504023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150173

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-04-23
• Device Publish Date: 2016-09-24

On-Brand Devices [AEROBIKA OPEP with Manometer]

• 62860110504023: AEROBIKA OPEP with Manometer (package of 10)
• 10762860105048: AEROBIKA OPEP with Manometer