FDA.reportPublic FDA data

OxyBREATH NON-MEASURING EXERCISER

Primary DI
00851232007738
Brand
OxyBREATH NON-MEASURING EXERCISER
Company
D R BURTON HEALTHCARE, LLC
Model
1
Catalog number
564
Device description
The OxyBREATH is a respiratory muscle trainer (RMT). It trains both inspiratory and expiratory muscles independently.
Published
2026-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192000000D R Burton OxyPAPD R Burton Healthcare, LLC2020-02-19BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20851232007732PackageGS110In Commercial Distribution
00851232007738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085123200773220851232007732
00851232007738008512320077388512320077380851232007738

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP unit ambient air filter, reusableA non-sterile filter designed to be installed in a continuous positive airway pressure (CPAP) and/or bi-level positive airway pressure (BPAP) unit to filter particulates from the ambient air prior to inhalation; it is not intended to filter medical gases. It is typically a flat sheet or pad composed of tightly woven materials or foam intended to be installed over the air inlet of the CPAP/BPAP device to remove particulates/impurities; it is not intended to filter microbes. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
2522287038inquiries@drburtonhpi.com

Regulatory Flags#

DUNS number
080384219
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851232007011vPEP OPEP DEVICE15102017-01-27
00851232007028vPEP-HC15122018-10-24
00851232007080vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTER1512-T2026-04-28
00851232007097T-PIECE ADAPTER15522019-08-23
00851232007103T-PIECE ADAPTER15562019-08-23
00851232007110J-Wand Advantage15952019-07-03
00851232007127vPEP15022026-04-28
00851232007134OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTER1562-TS, 562-62026-04-28
00851232007141OxyPAP PAP DEVICE w/o MANOMETER15632026-04-28
00851232007158OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETER1563-TS, 563-62026-04-28
00851232007165RTech REUSABLE INTUBATION STYLET 15972026-04-28
00851232007172RTech STERILE DISPOSABLE INTUBATION STYLET1597-D2026-04-28
00851232007189RTech NON-STERILE DISPOSABLE INTUBATION STYLET1597-NSD2026-04-28
00851232007196J-WAND ADVANTAGE INTUBATION STYLET, NON-STERILE1595-NS2026-04-28
00851232007202OXYJET VENTURI DEVICE WITH TUBING15612026-04-28
00851232007530iPEP15202018-01-02
00851232007554PocketPEP Advantage15352021-07-01
00851232007578PocketPEP15302018-01-02
00851232007585PocketPEP OPEP DEVICE w/ T-PIECE ADAPTER & MOUTHPIECE15332026-04-28
00851232007653NUT AND NIPPLE ADAPTOR 15552026-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007745OxyTrainer ADVANTAGED R BURTON HEALTHCARE, LLCION2026-04-28
08018294018009AirFeel IMTFLAEM NUOVA SPAION2026-02-18
18018294018006AirFeel IMTFLAEM NUOVA SPAION2026-02-18
00860014768620MouthflexINNOMOTIVE L.L.CION2026-02-11
08054040402029FRAME RUNNERORMESA SRLION2025-10-15
08054040402036FRAME RUNNERORMESA SRLION2025-10-15
08054040401275FRAME RUNNERORMESA SRLION2025-09-20
08054040401282FRAME RUNNERORMESA SRLION2025-09-20
08054040401299FRAME RUNNERORMESA SRLION2025-09-20
08054040401305FRAME RUNNERORMESA SRLION2025-09-20
08054040401312FRAME RUNNERORMESA SRLION2025-09-20
08054040401329FRAME RUNNERORMESA SRLION2025-09-20
08054040401336FRAME RUNNERORMESA SRLION2025-09-20
08054040401343FRAME RUNNERORMESA SRLION2025-09-20
08054040401350FRAME RUNNERORMESA SRLION2025-09-20
08054040401367FRAME RUNNERORMESA SRLION2025-09-20
08054040401374FRAME RUNNERORMESA SRLION2025-09-20
08054040401381FRAME RUNNERORMESA SRLION2025-09-20
08054040401398FRAME RUNNERORMESA SRLION2025-09-20
08054040401404FRAME RUNNERORMESA SRLION2025-09-20
08054040401411FRAME RUNNERORMESA SRLION2025-09-20
08054040401428FRAME RUNNERORMESA SRLION2025-09-20
08054040401435FRAME RUNNERORMESA SRLION2025-09-20
08054040401442FRAME RUNNERORMESA SRLION2025-09-20
00384703160019EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703150010EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00384703155015EmpelvicOWEN MUMFORD USA INCORPORATEDION2025-08-22
00810188050557Vector BaseBioness Medical, Inc.ION2025-07-18
00616784050010Pedal Exerciser, Non-Folding, Hands/FeetDynarex CorporationION2025-05-29
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