KENOREX

Primary DI
10852244007379
Brand
KENOREX
Company
KENTRON HEALTHCARE, INC.
Model
712320
Catalog number
712320
Device description
PEEP VALVE DISPOSABLE 5-20 CMS WATER PRESSURE, 30 MM ID
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BYEAttachment, Breathing, Positive End Expiratory Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYEAttachment, Breathing, Positive End Expiratory PressureAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160112000Besmed PEEP ValveBesmed Health Business Corp2016-04-29BYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852244007372PackageGS120In Commercial Distribution
10852244007379PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852244007372008522440073728522440073720852244007372
1085224400737910852244007379

GMDN Terms#

Term, Definition table
TermDefinition
PEEP valve, single-useA non-sterile device used in a respiratory or anaesthesia breathing circuit or system to maintain a selected level of positive end expiratory pressure (PEEP) in a patient's airway during ventilation. The device is typically constructed of plastic and metal materials, and has a valve(s) actuated with a spring(s) to provide the airway resistance, and an adjustable knob or dial (usually graduated) to adjust the resistance level typically between 5 to 20 cmH2O. It is used with ventilators, stand-alone breathing systems for oxygen delivery, pulmonary resuscitators, or anaesthetic breathing systems often having an expiratory valve function. 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
00810003750396KENTRON7399202026-05-27
00810003750402KENTRON7399252026-05-27
00810003750419KENTRON7399302026-05-27
00810003750426KENTRON7399352026-05-27
00810003750433KENTRON7399402026-05-27
00810003750440KENTRON7399452026-05-27
00810003750457KENTRON7399502026-05-27
00810003750464KENTRON7399552026-05-27
00810003750471KENTRON7399602026-05-27
00810003750488KENTRON7399652026-05-27
00810003755896KENOREX3811002026-05-18
00810003755902KENOREX3811102026-05-18
00810003755919KENOREX3811202026-05-18
00810003755926KENOREX3811302026-05-18
00810003755933KENOREX3811402026-05-18
00810003755940KENOREX3811502026-05-18
00810003755957KENOREX8877102026-05-18
00810003752000KENOREX3935062026-05-17
00810003752017KENOREX3935082026-05-17
00810003752024KENOREX3935102026-05-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094578534Curaplex®BOUND TREE MEDICAL, LLCBYE2025-08-06
00810094578008Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578015Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578022Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578039Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00810094578046Curaplex®BOUND TREE MEDICAL, LLCBYE2025-07-09
00026072001479EMAllied Medical, LLCBYE2024-05-28
00810094574987CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094575007CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094574994CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
00810094575014CuraplexBOUND TREE MEDICAL, LLCBYE2023-02-28
10884521831643ShileyCovidien LPBYE2023-02-18
10884521831636ShileyCovidien LPBYE2023-02-16
00810071637261CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
00810071637278CuraplexBOUND TREE MEDICAL, LLCBYE2022-12-30
00709078013560Bracket with Tube GuideWESTMED, INC.BYE2021-10-15
00709078013546WaterPAP Pole ClampWESTMED, INC.BYE2021-10-08
00709078013607WaterPAP™ Starter KitWESTMED, INC.BYE2021-10-08
00709078013621WaterPAP™ Pro Starter KitWESTMED, INC.BYE2021-10-08
00709078013195WaterPAPWESTMED, INC.BYE2021-08-31
10641043574041Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
10641043574058Flow-Safe II+ BiLevel Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2021-01-14
10641043572443Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10641043572450Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
10641043572467Flow-Safe II Disposable CPAP SystemMERCURY ENTERPRISES, INC.BYE2020-11-12
08498840012130VYGONVygon CorporationBYE2020-03-12
15019315061066PortexICU MEDICAL, INC.BYE2020-03-12
15019315061073PortexICU MEDICAL, INC.BYE2020-03-12
15019315061080PortexICU MEDICAL, INC.BYE2020-03-12
10190752133181AirLife™AIRLIFEBYE2020-01-15