FDA.reportPublic FDA data

DEFENDO

Primary DI
50724995228946
Brand
DEFENDO
Company
MEDIVATORS INC.
Model
Defendo Fujifilm 700 Series
Catalog number
100333
Device description
Defendo for Fuji 700, 4-piece Single Use Valve Kit with Air Water, Suction, Biopsy Valve and Connector
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
FEQPUMP, AIR, NON-MANUAL, FOR ENDOSCOPE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEQPump, Air, Non-Manual, For EndoscopeGastroenterology, 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
50724995228946PackageGS150In Commercial Distribution
00724995228941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522894650724995228946
00724995228941007249952289417249952289410724995228941

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic suction valve, single-useA device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. 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
00191506038892HydraBOSTON SCIENTIFIC CORPORATIONFEQ2024-10-07
50724995228908DEFENDOMEDIVATORS INC.FEQ2024-01-18
50724995228922DEFENDOMEDIVATORS INC.FEQ2024-01-18
04065655000375ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000405ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000825ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000863ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000894ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000924ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655000955ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655000986ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001013ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
04065655001044ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001075ERBEFLO AeroRinse®Erbe Medical, LLCFEQ2023-09-22
04065655001105ERBEFLO CleverCap®Erbe Medical, LLCFEQ2023-09-22
15019778005072OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFEQ2023-07-05
15019778005089OlympusKEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITEDFEQ2023-07-05
40677964031593ENDOGATORMEDIVATORS INC.FEQ2022-07-29
50603468009506CS-10-00-300 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468009674CS-10-30-300 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468009742CS-10-00-315 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468009810CS-10-30-315 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468009988CS-10-00-330 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
50603468010014CS-10-30-330 OpClear DisposableCIPHER SURGICAL LIMITEDFEQ2021-10-01
10724995183810AquaShieldUS EndoscopyFEQ2020-04-01
10724995183827AquaShieldUS EndoscopyFEQ2020-04-01
10724995183834AquaShieldUS EndoscopyFEQ2020-04-01
10724995183841AquaShieldUS EndoscopyFEQ2020-04-01
10724995183858AquaShieldUS EndoscopyFEQ2020-04-01
10724995183865AquaShieldUS EndoscopyFEQ2020-04-01