Lung Flute® for Home Care 1003-01
GUDID 20816133010014
Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy
MEDICAL ACOUSTICS LLC
Mechanical positive pressure airway secretion-clearing device Mechanical positive pressure airway secretion-clearing device Mechanical positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device Positive pressure airway secretion-clearing device| Primary Device ID | 20816133010014 |
| NIH Device Record Key | 03cc4e5d-fb5b-477f-9561-2adff02d36f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lung Flute® for Home Care |
| Version Model Number | 1003-01 |
| Catalog Number | 1003-01 |
| Company DUNS | 059669559 |
| Company Name | MEDICAL ACOUSTICS LLC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com | |
| Phone | 1-888-820-0970 |
| sales@medicalacoustics.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816133010010 [Primary] |
| GS1 | 10816133010017 [Package] Contains: 00816133010010 Package: Carton [10 Units] In Commercial Distribution |
| GS1 | 20816133010014 [Package] Contains: 10816133010017 Package: Case [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K091557
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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-01-31 |
Devices Manufactured by MEDICAL ACOUSTICS LLC
| 20816133010007 - Lung Flute® for Hospitals & Clinics | 2018-07-06 Secretion Mobilization and Induction Device Dual-Indication for Diagnostic & Therapeutic Use |
| 20816133010014 - Lung Flute® for Home Care | 2018-07-06Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy |
| 20816133010014 - Lung Flute® for Home Care | 2018-07-06 Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy |
| 20816133010083 - Lung Flute® Therapeutic | 2018-07-06 Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy |
Trademark Results [Lung Flute]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUNG FLUTE 97086949 not registered Live/Pending |
Acoustic Innovations LLC 2021-10-21 |
 LUNG FLUTE 86177725 4612904 Live/Registered |
Medical Acoustics, LLC 2014-01-28 |
 LUNG FLUTE 78171154 2830865 Dead/Cancelled |
Medical Acoustics, LLC 2002-10-04 |
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