FDA.reportPublic FDA data

NAPA

Primary DI
00860898002605
Brand
NAPA
Company
DRW MEDICAL LLC
Model
Bracket
Catalog number
AC-BR
Device description
Bracket
Published
2018-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K172284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172284000NAPA LP-15 Airway Pressure MonitorDrw Medical, LLC2018-02-09CAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860898002605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860898002605008608980026058608980026050860898002605

GMDN Terms#

Term, Definition table
TermDefinition
Airway pressure monitor, poweredA mains electricity (AC-powered) device designed to continuously measure and display the pressure values, positive and/or negative, in the upper airway (e.g., the maximal averaged inspiratory and expiratory static mouth pressure, and/or negative pressure generated by the patient during inspiration), typically in the assessment of patients with compromised pulmonary function and to determine the appropriateness of discontinuing mechanical ventilation. It typically includes a pressure indicator and a built-in alarm to signal pressure levels that exceed specific limits. It may contain batteries for independent operation when line-power is not available.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080686360
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860898002636NAPASample Line KitAC-MT2018-12-03
00860898002643NAPAAirway Pressure MonitorLP-152018-12-03
00860898002612NAPAPole Mounting ClampAC-PC2018-12-03
00860898002629NAPAPower SupplyAC-PS2018-12-03
10860898002633NAPASample Line KitAC-MT2018-12-03
00860898002650NAPAAirway Pressure MonitorLP-152018-12-03

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