FDA.reportPublic FDA data

The Breather

Primary DI
08652020001004
Brand
The Breather
Company
Pn Medical Inc
Model
1
Device description
Inspiratory Expiratory Muscle Trainer
Published
2021-05-18
Public version status
Update
Distribution status
Not 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
K944412000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944412000THE BREATHERPal Medical, Inc.1995-04-26BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08652020001004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08652020001004086520200010048652020001004

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser used in respiratory therapy to encourage and motivate deep-breathing manoeuvres, typically for the postsurgical treatment and prevention of atelectasis (lung collapse) and to help facilitate airway opening and clearing. It typically includes an indicator in a housing that rises in relation to patient inspiratory effort, performed via an attached tube and mouthpiece, to determine the maximum volume of gas which can be inspired [i.e., the inspiratory vital capacity (IVC)]. This is a single-patient device designed for use in a medical facility or in the home. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8774144449care@pnmedical.com

Regulatory Flags#

DUNS number
020298966
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00865202000131The Breathernon medical2023-01-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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