FDA.reportPublic FDA data

Defendo Single Use Valve Kit

Primary DI
00724995246778
Brand
Defendo Single Use Valve Kit
Company
MEDIVATORS INC.
Model
100313
Catalog number
100313
Device description
Defendo Fujifilm 500-600 Air-Water, Suction, and Biopsy Valve, 3-piece kit
Published
2026-04-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope and accessories, flexible/rigid
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDFColonoscope And Accessories, Flexible/RigidGastroenterology, Urology2
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090851000
K102409000
K102581000
K232067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090851000DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)Byrne Medical, Inc.2009-07-02ODC
K102409000DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304Byrne Medical, Inc.2010-11-04ODC
K102581000DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305Byrne Medical, Inc.2010-11-08ODC
K232067000Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use ConnectorMedivators (A Subsidiary of Steris Corporation)2024-03-22ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10724995246775PackageGS150In Commercial Distribution
50724995246773PackageGS12In Commercial Distribution
00677964094699PreviousGS10
00724995246778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499524677510724995246775
5072499524677350724995246773
00677964094699006779640946996779640946990677964094699
00724995246778007249952467787249952467780724995246778

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope channel support kitA collection of sterile devices intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It typically includes an endoscopic suction valve, an endoscopic air/water valve, and an endoscopic biopsy valve. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
068199363
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00677964021695CER-1CER-178399-7232016-09-20
00677964033858DSD-201DSD-201 120VDSD20172016-09-20
00677964035647SSD-102SSD-102SSD20072016-09-20
00677964044755Advantage Plus Endoscope Reprocessing System1-2-510.0032016-09-16
00677964046674DSD Edge Endoscope Reprocessing SystemDSD Edge 120VDSD30082016-09-16
00677964052484CER-1 OptimaCER-1 OptimaCER1OPTIMA2016-09-20
00677964052491CER-2 OptimaCER-2 OptimaCER2OPTIMA2016-09-20
00677964095832Advantage Plus Pass-Thru1-2-610.003126100032018-02-06
00677964153877Endo Carry-on Procedure Kit401137340113732026-07-20
00677964153921Endo Carry-on Procedure Kit401139040113902026-07-20
00677964153976Endo Carry-on Procedure Kit401141240114122026-07-20
00677964154089Endo Carry-on Procedure Kit401144940114492026-07-20
00677964154096Endo Carry-on Procedure Kit401146040114602026-07-20
00677964051555Medivators HookupHookup58112CAS2024-04-01
00677964053450Medivators HookupHookup28338CAS2024-04-01
00677964002328Medivators HookupHookup28718CAS2023-04-10
00677964037856Medivators HookupHookup28612CAS2023-04-10
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920035PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920066PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920141PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920271PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920295PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920394PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826920462PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921599PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921742PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826921759PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922176PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922183PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826922190PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925672PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925702PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826925832PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926068PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926075PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926082PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926099PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926112PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926136PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926143PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926150PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926228PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926273PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826926280PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826927560PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25
04580826928413PENTAX MedicalPENTAX MEDICAL CORPORATIONODC2026-08-25
04580826928420PENTAX MedicalPENTAX MEDICAL CORPORATIONFDF2026-08-25