AirPhysio

GUDID B99893699980215050

mucus clearance average lung capacity, OPEP, non invitro, no chemicals, contains one steel ball bearing TEAL coloured box

AIRPHYSIO PTY. LTD.

Positive pressure airway secretion-clearing device

• Primary Device ID: B99893699980215050
• NIH Device Record Key: 08bb5111-b497-4476-97d9-3fb1f8ee9595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirPhysio
• Version Model Number: 1
• Company DUNS: 744023767
• Company Name: AIRPHYSIO PTY. LTD.
• Device Count: 1
• DM Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B99893699980215050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203209

FDA Product Code

• BYI: Percussor, Powered-Electric

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: 2024-01-30
• Device Publish Date: 2024-01-22