The Breather

GUDID 08652020001004

Inspiratory Expiratory Muscle Trainer

Pn Medical Inc

Incentive spirometer

• Primary Device ID: 08652020001004
• NIH Device Record Key: a8da49cb-3611-47ea-b806-0fe5f91a147f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Breather
• Version Model Number: 1
• Company DUNS: 020298966
• Company Name: Pn Medical Inc
• 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: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com
• Phone: 8774144449
• Email: care@pnmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08652020001004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944412

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: 2021-05-26
• Device Publish Date: 2021-05-18

On-Brand Devices [The Breather]

• 08652020001004: Inspiratory Expiratory Muscle Trainer
• 00865202000124: Inspiratory Expiratory Muscle Trainer