FDA.reportPublic FDA data

KENOREX

Primary DI
10852244007362
Brand
KENOREX
Company
KENTRON HEALTHCARE, INC.
Model
779504
Catalog number
779504
Device description
RESUSCITATOR MANOMETER 0-60 CMS WATER 30 MM ID
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K140370000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140370000DISPOSABLE PRESSURE MANOMETERBesmed Health Business Corp2014-06-19CAP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852244007365PackageGS120In Commercial Distribution
10852244007362PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852244007365008522440073658522440073650852244007365
1085224400736210852244007362

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
615-384-0573kentron@kentronmedical.com

Regulatory Flags#

DUNS number
618825723
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750495KENTRON7499252026-06-01
00810003750501KENTRON7499302026-06-01
00810003750518KENTRON7499352026-06-01
00810003750525KENTRON7499402026-06-01
00810003750532KENTRON7499452026-06-01
00810003750549KENTRON7499502026-06-01
00810003750556KENTRON7499552026-06-01
00810003750563KENTRON7499602026-06-01
00810003750570KENTRON7499652026-06-01
00810003750587KENTRON7499702026-06-01
00810003750594KENTRON7499752026-06-01
00810003750600KENTRON7499802026-06-01
00810003750617KENTRON7499852026-06-01
00810003750624KENTRON7499902026-06-01
00810003750631KENTRON7499952026-06-01
00810003750648KENTRON7491002026-06-01
00810003750655KENTRON7699252026-06-01
00810003750662KENTRON7699302026-06-01
00810003750679KENTRON7699352026-06-01
00810003750686KENTRON7699402026-06-01

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