Breather Voice

GUDID 00850021574116

Pn Medical Inc

Tongue/lip exerciser

• Primary Device ID: 00850021574116
• NIH Device Record Key: e57d7349-9e97-4d7b-9cbf-513d8477bff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breather Voice
• Version Model Number: B-Voice
• Company DUNS: 020298966
• Company Name: Pn Medical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021574116 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2024-09-17
• Device Publish Date: 2024-09-09

Devices Manufactured by Pn Medical Inc

• 01240000013849 - Breather X: 2024-10-08
• 00850021574116 - Breather Voice: 2024-09-17
• 00850021574116 - Breather Voice: 2024-09-17
• 00865202000117 - Breather Recover: 2024-09-17
• 00865202000148 - Breather Fit: 2024-09-17
• 00865202000193 - The Breather Pink: 2024-09-17
• 00865202000124 - The Breather: 2021-10-19 Inspiratory Expiratory Muscle Trainer
• 08652020001004 - The Breather: 2021-05-26 Inspiratory Expiratory Muscle Trainer