FDA.reportPublic FDA data

Disposable Pressure Manometer

Primary DI
50851232007757
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
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
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
50851232007757PackageGS150In Commercial Distribution
10851232007759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5085123200775750851232007757
1085123200775910851232007759

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
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