FDA.reportPublic FDA data

Lung Flute® for Home Care

Primary DI
20816133010014
Brand
Lung Flute® for Home Care
Company
MEDICAL ACOUSTICS LLC
Model
1003-01
Catalog number
1003-01
Device description
Secretion Mobilization Device for PEP/Bronchial Hygiene Therapy
Published
2017-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWFSpirometer, Therapeutic (Incentive)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWFSpirometer, Therapeutic (Incentive)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091557000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091557000LUNG FLUTE THERAPEUTICMedical Acoustics2010-01-04BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816133010017PackageGS110In Commercial Distribution
20816133010014PackageGS15In Commercial Distribution
00816133010010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081613301001710816133010017
2081613301001420816133010014
00816133010010008161330100108161330100100816133010010

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical positive pressure airway secretion-clearing deviceA hand-held, mechanical device designed to remove excessive mucus or sputum (phlegm) from the lungs and upper airway of a patient typically suffering from acute or chronic lung disease. A positive expiratory pressure (PEP) is created when a patient exhales into the device, typically causing a high-density stainless steel ball to rapidly fluctuate up and down to create vibrations in the chest wall which loosens the mucus for expectoration and also assists 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
059669559
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816133010003Lung Flute® for Hospitals & Clinics1004-011004-012017-01-31
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
20816133010083Lung Flute® Therapeutic1005-011005-012017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305610MaxiPEPENCHANT TEK. CO, LTD.BWF2026-05-28
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00851232007127vPEPD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007134OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007141OxyPAP PAP DEVICE w/o MANOMETERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007158OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007585PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECED R BURTON HEALTHCARE, LLCBWF2026-04-28
10197344010332HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
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