7117185FKN

GUDID 00724995201784

The Fujinon Leak Test Adapter is used with the Acu-sinQ Complete Endoscope Cleaning Aid System.

Corporation Steris Canada

Endoscope leak tester, mechanical
Primary Device ID00724995201784
NIH Device Record Key3f062195-1dd2-47fe-acf2-a7767538bd5e
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberAcu-sInQ Leak Test
Catalog Number7117185FKN
Company DUNS202659140
Company NameCorporation Steris Canada
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995167776 [Previous]
GS100724995201784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FEBAccessories, cleaning, for endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-26
Device Publish Date2020-10-16

Devices Manufactured by Corporation Steris Canada

00724995217433 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217440 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217457 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217464 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217471 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217488 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217495 - enspire2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
00724995217501 - enspire2024-04-25 The enspire 3000 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.