FDA.reportPublic FDA data

The Breather

Primary DI
00865202000131
Brand
The Breather
Company
Pn Medical Inc
Model
non medical
Published
2023-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
IONExerciser, Non-Measuring

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00865202000131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00865202000131008652020001318652020001310865202000131

GMDN Terms#

Term, Definition table
TermDefinition
Tongue/lip exerciserA hand-held mechanical device intended to provide resistance to tongue and/or lip movements for rehabilitation of oral motor function, typically to aid in swallow and speech therapy, following impairment (e.g., dysphagia, dysarthria) from stroke or other neurological conditions. It consists of an intraoral bulb with a connected handle, similar to an infant pacifier in appearance, made of flexible silicone. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
020298966
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08652020001004The Breather12021-05-18
01240000013849Breather X12024-09-30
00850021574116Breather VoiceB-Voice2024-09-09
00865202000117Breather RecoverB-Recover2024-09-09
00865202000148Breather FitB-Fit2024-09-09
00865202000193The Breather PinkB-Pink2024-09-09
00865202000124The Breather12021-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007738OxyBREATH NON-MEASURING EXERCISERD R BURTON HEALTHCARE, LLCION2026-04-28
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