FDA.reportPublic FDA data

DEFENDO

Primary DI
50724995228939
Brand
DEFENDO
Company
MEDIVATORS INC.
Model
Defendo Fujifilm 700 Series
Catalog number
100331
Device description
Defendo for Fuji 700, 4-piece Single Use Air Water, Suction, Connector and Cleaning Adapter Kit
Published
2024-01-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDFColonoscope and accessories, flexible/rigid

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232329000Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning AdapterMedivators (A Subsidiary of Steris Corporation)2023-12-21ODC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995228939PackageGS150In Commercial Distribution
00724995228934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522893950724995228939
00724995228934007249952289347249952289340724995228934

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags#

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995229641DEFENDO400805540080552024-03-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809882470213ROBOPERA™ SETEndoRobotics Co., Ltd.FDF2026-10-16
08809882470220Articulated Basic Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470237Articulated Dual Gripper GEndoRobotics Co., Ltd.FDF2026-10-16
08809882470381ROBOPERA™ UnitEndoRobotics Co., Ltd.FDF2026-10-16
08809882470398ROBOPERA™EndoRobotics Co., Ltd.FDF2026-10-16
08809882470404Controller AEndoRobotics Co., Ltd.FDF2026-10-16
08809882470428Controller BEndoRobotics Co., Ltd.FDF2026-10-16
08809882470442ROBOPERA™ AccessoriesEndoRobotics Co., Ltd.FDF2026-10-16
08809882470466R-Power CableEndoRobotics Co., Ltd.FDF2026-10-16
08809882470725ROBOPERA™ Storage CaseEndoRobotics Co., Ltd.FDF2026-10-16
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
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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