FDA.reportPublic FDA data

vPEP

Primary DI
00851232007127
Brand
vPEP
Company
D R BURTON HEALTHCARE, LLC
Model
1
Catalog number
502
Device description
Single patient, multi use, hand held secretion clearance and lung expansion device that creates vibrating positive expiratory pressure when the patient exhales through the device.
Published
2026-04-28
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
K160636000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160636000iPEP System and vPEPD R Burton Healthcare, LLC2016-08-03BWF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20851232007121PackageGS12In Commercial Distribution
00851232007127PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085123200712120851232007121
00851232007127008512320071278512320071270851232007127

GMDN Terms#

Term, Definition table
TermDefinition
Incentive spirometerA hand-held, mechanical, breathing-muscle exerciser intended to be 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 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 and in the home. 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
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
00851232007677T-PIECE ADAPTER15572019-08-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851232007080vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTERD 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
10197344010349HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10197344010356HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010339HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010346HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
20197344010353HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2026-01-23
10889483642313AirLife™SUNMED, LLCBWF2025-07-31
10889483642320AirLife™SUNMED, LLCBWF2025-07-31
30889483642317AirLife™SUNMED, LLCBWF2025-07-31
30889483642324AirLife™SUNMED, LLCBWF2025-07-31
10197344097715HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
20197344097712HUDSON RCIMEDLINE INDUSTRIES, INC.BWF2025-07-23
10889483570692AirLife™AIRLIFEBWF2025-02-20
30889483570696AirLife™Sunmed Group Holdings, LLCBWF2025-02-20
10889483570807AirLife™AIRLIFEBWF2025-02-11
10889483570814AirLife™AIRLIFEBWF2025-02-11
10889483570821AirLife™AIRLIFEBWF2025-02-11
10889483570838AirLife™AIRLIFEBWF2025-02-11
10889483570845AirLife™AIRLIFEBWF2025-02-11
30889483570801AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570818AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570825AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570832AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
30889483570849AirLife™Sunmed Group Holdings, LLCBWF2025-02-11
10885632429774HalyardOWENS & MINOR DISTRIBUTION, INC.BWF2025-02-06