FDA.reportPublic FDA data

Lung Flute® for Hospitals & Clinics

Primary DI
00816133010003
Brand
Lung Flute® for Hospitals & Clinics
Company
MEDICAL ACOUSTICS LLC
Model
1004-01
Catalog number
1004-01
Device description
Secretion Mobilization and Induction DeviceDual-Indication for Diagnostic & Therapeutic Use
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)
BYIPercussor, Powered-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2
BYIPercussor, Powered-ElectricAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816133010000PackageGS110In Commercial Distribution
20816133010007PackageGS15In Commercial Distribution
00816133010003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081613301000010816133010000
2081613301000720816133010007
00816133010003008161330100038161330100030816133010003

GMDN Terms#

Term, Definition table
TermDefinition
Positive pressure airway secretion-clearing deviceA hand-held, non-powered device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airways using positive pressure airway (PEP) to treat patients affected by acute or chronic lung disease. PEP is created when a patient exhales into the device which creates vibrations in the chest by various means (e.g., an oscillating ball or creating bubbles in a solution within the device) loosening the mucus for expectoration and assisting in lung expansion. Also known as an oscillating positive expiratory pressure (OPEP) device, it is a single-patient device designed for use both in a healthcare facility and in the home. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-888-820-0970sales@medicalacoustics.com

Regulatory Flags#

DUNS number
059669559
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816133010010Lung Flute® for Home Care1003-011003-012017-01-31
00816133010089Lung Flute® Therapeutic1005-011005-012017-01-31
20816133010007Lung Flute® for Hospitals & Clinics1004-011004-012017-01-31
20816133010014Lung Flute® for Home Care1003-011003-012017-01-31
20816133010083Lung Flute® Therapeutic1005-011005-012017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841470100841PercussorPULMODYNE INCBYI2026-05-29
00841470100858PercussorPULMODYNE INCBYI2026-05-29
04719882305610MaxiPEPENCHANT TEK. CO, LTD.BWF2026-05-28
00816305024890AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024906AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024913AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024920AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305024937AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025101AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025248AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025255AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025262AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025279AffloVestTactile Systems Technology, Inc.BYI2026-05-27
00816305025286AffloVestTactile Systems Technology, Inc.BYI2026-05-27
10197344010332HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10197344010349HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10197344010356HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10889483563113BALLARD™SUNMED, LLCBYI2025-12-01
10889483642313AirLife™SUNMED, LLCBWF2025-07-31
10889483642320AirLife™SUNMED, LLCBWF2025-07-31
10197344097715HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
10889483570692AirLife™AIRLIFEBWF2025-02-20
10889483570807AirLife™AIRLIFEBWF2025-02-11
10889483570814AirLife™AIRLIFEBWF2025-02-11
10889483570821AirLife™AIRLIFEBWF2025-02-11
10889483570838AirLife™AIRLIFEBWF2025-02-11
10889483570845AirLife™AIRLIFEBWF2025-02-11
10885632429774HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
10885632429781HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06
10885632429798HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06