FDA.reportPublic FDA data

DPM

Primary DI
00841470111410
Brand
DPM
Company
PULMODYNE INC
Model
313-5558
Published
2018-03-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K003497000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003497000DISPOSABLE PRESSURE MONITOREngineered Medical Systems2000-11-30CAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841470111417PackageGS110In Commercial Distribution
00841470111410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084147011141710841470111417
00841470111410008414701114108414701114100841470111410

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.

Regulatory Flags#

DUNS number
030619483
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841470100841Percussor313-41962026-05-29
00841470100858Percussor313-41972026-05-29
00841470104740BiTrac Select313-95892025-09-30
00841470104764BiTrac Select313-95912025-09-30
00841470100148O2-MAX313-8201-62025-04-12
00841470105501BiTrac101615782025-04-11
00841470105518BiTrac 101615772025-04-11
00841470105525BiTrac101615792025-04-11
00841470105532BiTrac101615762025-04-11
00841470105549BiTrac 101600492025-04-11
00841470105556BiTrac 101600502025-04-11
00841470105563BiTrac 101600512025-04-11
00841470105570BiTrac 101600522025-04-11
00841470105587BiTrac SE101600532025-04-11
00841470105594BiTrac SE101600542025-04-11
00841470105600BiTrac SE101600552025-04-11
00841470105617BiTrac SE101600562025-04-11
00841470105631BiTrac Select101617662025-04-11
00841470105648BiTrac Select101617672025-04-11
00841470105655BiTrac Select101617682025-04-11

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
00841470111700Disposable Pressure ManometerENGINEERED MEDICAL SYSTEMS INCCAP2025-04-12
10841470111707Disposable Pressure ManometerENGINEERED MEDICAL SYSTEMS INCCAP2025-04-12
10889483587508AirLife™AIRLIFECAP2025-03-13
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