FDA.reportPublic FDA data

NA

Primary DI
00724995168346
Brand
NA
Company
Corporation Steris Canada
Model
7117161SKN
Catalog number
7117185SKN
Device description
KARL STORZ Leak Test Adaper- used with the Acu-sinQ Complete Endoscope Cleaning Aid System
Published
2019-02-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FEBAccessories, cleaning, for endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FEBAccessories, Cleaning, For EndoscopeGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181865000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181865000Acu-sInQ Complete Endoscope Cleaning Aid SystemSTERIS Corporation2018-12-14FEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995168346PrimaryGS10
00724995201807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995168346007249951683467249951683460724995168346
00724995201807007249952018077249952018070724995201807

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope leak tester, mechanicalA hand-operated device used to test a flexible endoscope for leaks from its internal channels. It is connected to the endoscope using tubing with connectors to subject the channels to a build-up of air pressure that is created with a hand pump (a bulb). Its manometer will display the pressure and leakage is indicated by a fall in pressure observed on the manometer gauge. It is typically used by healthcare personnel who use endoscopes to validate the patency of the endoscope prior to clinical use, or to substantiate suspicion of a leakage. This process is used as a first line test for early detection of pinhole leaks to minimize inadvertent incidences with the patient.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
202659140
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995094119NAC1201EC1201E2020-09-25
00724995094126NAC1221EC1221E2020-09-25
00724995094133NAC1141EC1141E2020-09-25
00724995090753NAC1202EC1202E2020-06-29
00724995090777NAC1222EC1222E2020-06-29
00724995090791NAC1142EC1142E2020-06-29
00724995090739NAC1160EC1160E2020-01-02
00724995090746NAC1200EC1200E2020-01-02
00724995090760NAC1220EC1220E2020-01-02
00724995090784NAC1140EC1140E2020-01-02
00724995157449NAC3000XLC3000XL2020-01-02
00724995170554SYSTEM 1 endo1 endoP69002019-10-04
00724995092986SYSTEM 1E Liquid Chemical Sterilant Processing System1E65002016-09-13
00724995196042AMSCO5052FH14042S0012020-09-04
00724995216504NAReliance 6000 ConnectorsRECT1CON7P2026-01-14
00724995151416NAMB000010MB0000102016-09-13
00724995151423NAMB000015MB0000152016-09-13
00724995194420NAFlow Unit 11EPSC011INT2020-04-30
00724995001544NAFlow Unit 8EPSC008INT2016-09-13
00724995001551NAFlow Unit 9EPSC009INT2016-09-13

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