FDA.reportPublic FDA data

AEROBIKA OPEP Manometer

Primary DI
00762860105027
Brand
AEROBIKA OPEP Manometer
Company
Trudell Medical International
Model
110502
Device description
AEROBIKA OPEP Manometer
Published
2020-04-22
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)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150173000Aerobika OPEP Devive with ManometerTrudell Medical International2015-10-15BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10762860105024PackageGS125In Commercial Distribution
62860110502029PreviousGS10
00762860105027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076286010502410762860105024
6286011050202962860110502029
00762860105027007628601050277628601050270762860105027

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
1-519-455-4862customerservice@trudellmed.com

Regulatory Flags#

DUNS number
203298203
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00762860000582OMBRA* Table Top Compressor System 105510105510940062025-11-06
00762860055100OMBRA 120V Table Top Compressor System1055102020-03-25
62860105509026AEROECLIPSE BAN Replacement Mouthpiece Assembly105509105509940802020-03-24
62860105501020AEROECLIPSE II Breath Actuated Nebulizer Disposable105501105501940502016-09-24
62860105505028AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter105505105505940502016-09-24
62860105506025AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable105506105506940502016-09-24
62860105507022AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator105507105507940102016-09-24
62860105513016AeroEclipse* XL Breath Actuated Nebulizer105513105510940062016-09-24
62860105514020EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN105514105514940102016-09-30
62860105541026AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing105541105541940502016-09-24
62860105542023AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing105542105542940502016-09-24
00762860001138RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
00762860055025REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
00762860055032REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
00762860055049REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
10762860001135RESPICHAMBER* VHC with Mouthpiece1015332024-03-11
10762860055022REUSABLE COMFORTSEAL® Silicone Mask Assembly1055022024-03-11
10762860055039REUSABLE COMFORTSEAL® Silicone Mask Assembly1055032024-03-11
10762860055046REUSABLE COMFORTSEAL® Silicone Mask Assembly1055042024-03-11
00762860000827AEROCHAMBER* MV Holding Chamber825918251100502023-12-01

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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