FDA.reportPublic FDA data

KENOREX

Primary DI
00810003751218
Brand
KENOREX
Company
KENTRON HEALTHCARE, INC.
Model
404086
Catalog number
404086
Device description
"VOMIT AND URINE CLEAR BAG (EMESIS) WITH INNER LEAK PROOF VALVE AND 6"" RIGID OPENING AT THE TOP"
Published
2018-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FNYBasin, Emesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810003751225PackageGS112In Commercial Distribution
00810003751232PackageGS120In Commercial Distribution
00810003751218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810003751225008100037512258100037512250810003751225
00810003751232008100037512328100037512320810003751232
00810003751218008100037512188100037512180810003751218

GMDN Terms#

Term, Definition table
TermDefinition
Emesis bagA disposable device intended to collect and contain a patient's vomit until it is convenient to dispose of it and its contents. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
615-384-0573KENTRON@KENTRONMEDICAL.COM

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810003750822KENTRON7599252026-06-08
00810003750839KENTRON7599302026-06-08
00810003750846KENTRON7599352026-06-08
00810003750853ENTRON7599402026-06-08
00810003750860KENTRON7599452026-06-08
00810003750877KENTRON7599502026-06-08
00810003750884KENTRON7599552026-06-08
00810003750891KENTRON7599602026-06-08
00810003750907KENTRON7599652026-06-08
00810003750709KENTRON7699502026-06-07
00810003750716KENTRON7699552026-06-07
00810003750723KENTRON7699602026-06-07
00810003750730KENTRON7699652026-06-07
00810003750747KENTRON7699702026-06-07
00810003750754KENTRON7699752026-06-07
00810003750761KENTRON7699802026-06-07
00810003750778KENTRON7699852026-06-07
00810003750785KENTRON7699902026-06-07
00810003750792KENTRON7699952026-06-07
00810003750808KENTRON7691002026-06-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918130552AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2026-04-17
10198956251335CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251342CARDINAL HEALTHCardinal Health 200, LLCFNY2026-01-12
10198956251359CARDINAL HEALTHCardinal Health 200, LLCFNY2025-12-10
10198956138193CARDINAL HEALTHCardinal Health 200, LLCFNY2025-11-07
00661392001176LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012356LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392012752LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392037977LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392053823LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
00661392055063LSL HEALTHCARELSL Industries, LLCFNY2025-10-30
10198956137714CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
16931918189192AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918190082AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
16931918129310AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918140827AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918145464AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918146843Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
16931918157085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00661392008083LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392025493LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392045330LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
00661392027664LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
00661392004627LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
10198956044890CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
10197106833780CARDINAL HEALTHCardinal Health 200, LLCFNY2024-12-31
10840330701355ProCureTwin Med, LLCFNY2024-11-14
10840330701362ProCureTwin Med, LLCFNY2024-11-14
10840330701379ProCureTwin Med, LLCFNY2024-11-14
10840330701386ProCureTwin Med, LLCFNY2024-11-14