AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

GUDID 00762860105010

AEROBIKA Oscillating Positive Expiratory Pressure Therapy System

Trudell Medical International

Mechanical positive pressure airway secretion-clearing device

• Primary Device ID: 00762860105010
• NIH Device Record Key: 79a4d622-b208-4612-acb0-c7d38564946a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AEROBIKA Oscillating Positive Expiratory Pressure Therapy System
• Version Model Number: 110501
• Company DUNS: 203298203
• Company Name: Trudell Medical International
• Device Count: 1
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00762860105010 [Primary]
GS1	10762860105017 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	20762860105014 [Package]; Contains: 10762860105017; Package: [80 Units]; In Commercial Distribution
GS1	30762860105011 [Package]; Package: [100 Units]; In Commercial Distribution
GS1	62860110501022 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123400

FDA Product Code

• BWF: Spirometer, Therapeutic (Incentive)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-26
• Device Publish Date: 2020-02-18

On-Brand Devices [AEROBIKA Oscillating Positive Expiratory Pressure Therapy System]

• 62860110501046: AEROBIKA Oscillating Positive Expiratory Pressure Therapy System
• 62860110501022: AEROBIKA Oscillating Positive Expiratory Pressure Therapy System (package of 10)
• 00762860105010: AEROBIKA Oscillating Positive Expiratory Pressure Therapy System