FDA.reportPublic FDA data

OxyPAP

Primary DI
10851232007711
Brand
OxyPAP
Company
D R BURTON HEALTHCARE, LLC
Model
1
Device description
The OxyPAP is a positive airway pressure (PAP) therapy device which incorporates a positive end expiratory pressure (PEEP) valve and which also has the ability to deliver supplemental oxygen when used with compressed oxygen.
Published
2020-02-24
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
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
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
30851232007715PackageGS110In Commercial Distribution
40851232007712PackageGS110In Commercial Distribution
50851232007719PackageGS110In Commercial Distribution
60851232007716PackageGS110In Commercial Distribution
10851232007711PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085123200771530851232007715
4085123200771240851232007712
5085123200771950851232007719
6085123200771660851232007716
1085123200771110851232007711

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, non-poweredA mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2522287038inquiries@drburtonhpi.com

Regulatory Flags#

DUNS number
080384219
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
true
Expiration date on label
false
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
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
04719882305610MaxiPEPENCHANT TEK. CO, LTD.BWF2026-05-28
00851232007080vPEP-HC OPEP DEVICE WITH T-PIECE ADAPTERD R BURTON HEALTHCARE, LLCBWF2026-04-28
00851232007127vPEPD 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
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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
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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
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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