FDA.reportPublic FDA data

NA

Primary DI
00724995201807
Brand
NA
Company
Corporation Steris Canada
Model
Acu-sInQ Leak Test
Catalog number
7117185SKN
Device description
The Karl Storz Leak Test Adapter is used with the Acu-sInQ Complete Endoscope Cleaning Aid System.
Published
2020-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
00724995168346PreviousGS10
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
Invasive medical device leak tester, mechanicalA hand-operated device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It is typically a hand pump (e.g., a bulb) with a manometer and controls intended to be connected to the device tested. This is a reusable device.

Contacts#

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

Regulatory Flags#

DUNS number
202659140
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
00724995201777NAAcu-sInQ Leak Test600832OKN2020-10-16
00724995201784NAAcu-sInQ Leak Test7117185FKN2020-10-16
00724995201791NAAcu-sInQ Leak Test7117185PKN2020-10-16
00724995176754NAFD024FD0242019-09-24
00724995150907NAFD026FD0262016-09-13
00724995151003NAFD111FD1112016-09-13
00724995151119NAFD70400FD704002016-09-13
00724995151195NAFD75500FD755002016-09-13
00724995151331NAFD81600FD816002016-09-13
00724995217433enspireenspire 300 SeriesENHLD300208VFD2024-04-17
00724995217440enspireenspire 300 SeriesENHLD300208VWD2024-04-17
00724995217457enspireenspire 300 SeriesENHLD300208NVFD2024-04-17
00724995217464enspireenspire 300 SeriesENHLD300208NVWD2024-04-17
00724995217471enspireenspire 300 SeriesENHLD300480VFD2024-04-17
00724995217488enspireenspire 300 SeriesENHLD300480VWD2024-04-17
00724995217495enspireenspire 300 SeriesENHLD300480NVFD2024-04-17
00724995217501enspireenspire 300 SeriesENHLD300480NVWD2024-04-17
00724995214395AMSCO1215FW121012021-08-13
00724995214401AMSCO1215FW121022021-08-13
00724995214418AMSCO1215FW121122021-08-13

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