FDA.reportPublic FDA data

DEFENDO

Primary DI
50724995228915
Brand
DEFENDO
Company
MEDIVATORS INC.
Model
Defendo Fujifilm 700 Series
Catalog number
100328
Device description
Defendo for Fuji 700, 4-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve, Cleaning Adapter
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
ODCEndoscope channel accessory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, 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
50724995228915PackageGS150In Commercial Distribution
00724995228910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522891550724995228915
00724995228910007249952289107249952289100724995228910

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
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14897106957894andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957948andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957955andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106958013andorate® 2-piece Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106958020andorate® 2-piece Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-13
14897106957917andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958556andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958587andorate® 3-piece Valve KitGA Health Company LimitedODC2026-03-12
14897106958617andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958624andorate® 4-piece valve kitGA Health Company LimitedODC2026-03-12
14897106958631andorate®Air Water Channel Cleaning Adapter + 3-piece Valve KitGA Health Company LimitedODC2026-03-12
14897106958648andorate® Air Water Channel Cleaning Adapter + 4-piece Valve KitGA Health Company LimitedODC2026-03-12
10724995247307NAMEDIVATORS INC.ODC2026-03-02
14897106957979andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106958532andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106958549andorate® 3-piece Valve KitGA Health Company LimitedODC2026-02-27
14897106957832Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957849Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957856Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957863Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957900Champion 3-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957924Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957931Air Water Channel Cleaning Adapter + Champion 4-piece Valve KitGA Health Company LimitedODC2026-01-21
14897106957962Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957986Champion 4-piece valve kitGA Health Company LimitedODC2026-01-21
14897106957993Air Water Channel Cleaning Adapter + Champion 3-piece Valve KitGA Health Company LimitedODC2026-01-21
00697314195036EndocleanChangzhou Endoclean Medical Device Co.,LtdODC2025-12-05
04953170467325SUCTION VALVE MAJ-1443OLYMPUS MEDICAL SYSTEMS CORP.ODC2025-09-25
04953170467332AIR/WATER VALVE MAJ-1444OLYMPUS MEDICAL SYSTEMS CORP.ODC2025-09-25