FDA.reportPublic FDA data

AEROBIKA OPEP with Manometer

Primary DI
10762860105048
Brand
AEROBIKA OPEP with Manometer
Company
Trudell Medical International
Model
110504
Device description
AEROBIKA OPEP with Manometer
Published
2020-02-18
Public version status
New
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
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
10762860105048PackageGS110In Commercial Distribution
62860110504023PreviousGS10
00762860105041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076286010504810762860105048
6286011050402362860110504023
00762860105041007628601050417628601050410762860105041

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

Regulatory Flags#

DUNS number
203298203
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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

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Primary DI, Brand, Company table
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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
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