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
00677964153617Endo Carry-on Procedure Kit401122140112212026-05-26
00677964153624Endo Carry-on Procedure Kit401124240112422026-05-26
00677964153631Endo Carry-on Procedure Kit401123040112302026-05-26
00677964153648Endo Carry-on Procedure Kit401124340112432026-05-26
00677964153655Endo Carry-on Procedure Kit401124440112442026-05-26
00677964153662Endo Carry-on Procedure Kit401124540112452026-05-26
00677964153679Endo Carry-on Procedure Kit401121440112142026-05-26
00677964153686Endo Carry-on Procedure Kit401123640112362026-05-26
00677964153693Endo Carry-on Procedure Kit401123740112372026-05-26
00677964153709Endo Carry-on Procedure Kit401123840112382026-05-26
00677964153716Endo Carry-on Procedure Kit401125040112502026-05-26
00677964153723Endo Carry-on Procedure Kit401125240112522026-05-26
00677964153730Endo Carry-on Procedure Kit401123940112392026-05-26
00677964153747Endo Carry-on Procedure Kit401125140112512026-05-26
00677964153754Endo Carry-on Procedure Kit401125340112532026-05-26
00677964153761Endo Carry-on Procedure Kit401125440112542026-05-26
00677964153778Endo Carry-on Procedure Kit401136040113602026-05-26
00677964153785Endo Carry-on Procedure Kit401136140113612026-05-26
50677964153056Endo Carry-on Procedure Kit401104140110412026-03-12
50677964153063Endo Carry-on Procedure Kit401104240110422026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04953170467349ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UE160-AL5OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-09-25
14547410477242FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477273FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
14547410477303FUJIFILMFUJIFILM CORPORATIONFDF2025-06-30
04953170425103COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04953170425158COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.FDF2025-05-26
04961333356478PENTAX MedicalHOYA CORPORATIONFDF2025-04-28
04961333129430PENTAXHOYA CORPORATIONFDF2025-04-04
04961333172085PENTAXHOYA CORPORATIONFDF2025-04-04
84953170463910BALLOON3OLYMPUS MEDICAL SYSTEMS CORP.FDF2025-02-25
00850458007041GripTract-GI Endoscopic Tissue ManipulatorACTUATED MEDICAL, INC.FDF2025-01-16
04961333254620PENTAX MedicalHOYA CORPORATIONFDF2024-12-13
04953170465970EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.FDF2024-11-25
06972520301094REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301100REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301117REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301124REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301179REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301186REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301193REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
06972520301209REDPINEGuangzhou Red Pine Medical Instrument Co., Ltd.FDF2024-09-02
04961333254781PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254460PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254811PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254477PENTAXHOYA CORPORATIONFDF2024-07-26
04961333254798PENTAXHOYA CORPORATIONFDF2024-07-26
B369MES01019MEDISONOMedisono, LLCFDF2023-11-17
B369MES01020MEDISONOMedisono, LLCFDF2023-11-17
B369MES01021MEDISONOMedisono, LLCFDF2023-11-17
B369MES01022MEDISONOMedisono, LLCFDF2023-11-17