FDA.reportPublic FDA data

Disposable Pressure Manometer

Primary DI
00851232007752
Brand
Disposable Pressure Manometer
Company
D R BURTON HEALTHCARE, LLC
Model
1
Catalog number
566
Device description
The disposable pressure manometer provides visual indication of airway pressure.
Published
2020-02-28
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
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAPMonitor, Airway Pressure (Includes Gauge And/Or Alarm)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
20851232007756PackageGS110In Commercial Distribution
50851232007757PackageGS150Not in Commercial Distribution
00851232007752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085123200775620851232007756
5085123200775750851232007757
00851232007752008512320077528512320077520851232007752

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.

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
00851232007134OxyPAP PAP DEVICE WITH UNIVERSAL CUFF ADAPTERD R BURTON HEALTHCARE, LLCCAP2026-04-28
00851232007141OxyPAP PAP DEVICE w/o MANOMETERD R BURTON HEALTHCARE, LLCCAP2026-04-28
00851232007158OxyPAP PAP DEVICE w/ 22mm MASK ADAPTOR w/o MANOMETERD R BURTON HEALTHCARE, LLCCAP2026-04-28
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCAP2026-04-15
04710810114380N/AGALEMED CORPORATIONCAP2026-03-05
04710810114427N/AGALEMED CORPORATIONCAP2026-03-05
04710810117008N/AGALEMED CORPORATIONCAP2026-03-05
44710810114388N/AGALEMED CORPORATIONCAP2026-03-05
44710810114425N/AGALEMED CORPORATIONCAP2026-03-05
44710810117006N/AGALEMED CORPORATIONCAP2026-03-05
07045432116151The BAG ManometerLaerdal Medical ASCAP2026-01-14
07045432116144The BAG ManometerLaerdal Medical ASCAP2026-01-14
14250892907243JaegerJaeger Medical GmbHCAP2025-11-24
14250892907250JaegerJaeger Medical GmbHCAP2025-11-24
14250892907267JaegerJaeger Medical GmbHCAP2025-11-24
14250892907274JaegerJaeger Medical GmbHCAP2025-11-24
14250892907281JaegerJaeger Medical GmbHCAP2025-11-24
14250892907946JaegerJaeger Medical GmbHCAP2025-07-29
14250892908004JaegerJaeger Medical GmbHCAP2025-07-29
14250892908011JaegerJaeger Medical GmbHCAP2025-07-29
14250892908028JaegerJaeger Medical GmbHCAP2025-07-29
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10889483587515AirLife™AIRLIFECAP2025-03-13
30889483587502AirLife™Sunmed Group Holdings, LLCCAP2025-03-13
30889483587519AirLife™Sunmed Group Holdings, LLCCAP2025-03-13
05055931102328FlexicareFLEXICARE MEDICAL LIMITEDCAP2024-03-05
05707480148882Ambu® Disposable Pressure ManometerAmbu A/SCAP2024-01-12
05707480148905Ambu® Disposable Pressure ManometerAmbu A/SCAP2024-01-12