FDA.reportPublic FDA data

NA

Primary DI
00724995087913
Brand
NA
Company
Corporation Steris Canada
Model
Flow Unit 4
Catalog number
EPSC004INT
Device description
The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Published
2016-09-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NZAAccessories, germicide, cleaning, for endoscopes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZAAccessories, Germicide, Cleaning, For EndoscopesGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040049000
K102244000
K200989000
K203223000
K220361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040049000THE RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2004-12-17NZA
K102244000RELIANCE ENDOSCOPE PROCESSING SYSTEMSTERIS Corporation2010-12-03NZA
K200989000Reliance Endoscope Processing SystemSTERIS Corporation2020-05-14NZA
K203223000Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSteris2021-01-28NZA
K220361000Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideSTERIS Corporation2022-03-10NZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995087913PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995087913007249950879137249950879130724995087913

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic device sterilization/disinfection tubing setA collection of devices, or a preassembled device, intended to allow connection between the appropriate port(s) of a sterilizer/disinfector and the channels, ports or distal end of an endoscope or endoscopic device (e.g., ultrasound transducer) during device sterilization and/or disinfection. It typically includes appropriate tubing, adaptors, and connectors to allow the appropriate fluids (sterilant or disinfectant) and gases to flow through the device, and might include a flow management unit. This is a reusable device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00724995214425AMSCO1215FW121072021-08-13
00724995214432AMSCO1215FW121172021-08-13
00724995214449AMSCO1215FW121052021-08-13
00724995214456AMSCO1215FW121152021-08-13
00724995214463AMSCO1215FW121032021-08-13
00724995214470AMSCO1215FW121132021-08-13
00724995176563AMSCO7052HPFH180822020-09-04
00724995176648AMSCO7053HPFH190822020-09-04
00724995192648Reliance VisionSingle ChamberFH050422020-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995193669RelianceCorporation Steris CanadaNZA2020-09-04
00724995193676RelianceCorporation Steris CanadaNZA2020-09-04
00724995193683RelianceCorporation Steris CanadaNZA2020-09-04
00724995193690RelianceCorporation Steris CanadaNZA2020-09-04
00724995193706RelianceCorporation Steris CanadaNZA2020-09-04
00724995194420NACorporation Steris CanadaNZA2020-04-30
04961333243044N/APENTAX OF AMERICA, INC.NZA2018-03-12
04961333243051N/APENTAX OF AMERICA, INC.NZA2018-03-12
00724995002619NACorporation Steris CanadaNZA2017-04-15
00724995000639NACorporation Steris CanadaNZA2016-09-13
00724995001544NACorporation Steris CanadaNZA2016-09-13
00724995001551NACorporation Steris CanadaNZA2016-09-13
00724995087883NACorporation Steris CanadaNZA2016-09-13
00724995087890NACorporation Steris CanadaNZA2016-09-13
00724995087906NACorporation Steris CanadaNZA2016-09-13
00724995087920NACorporation Steris CanadaNZA2016-09-13
00724995090630NACorporation Steris CanadaNZA2016-09-13
00724995152178RelianceCorporation Steris CanadaNZA2016-09-13
10724995083776RelianceSTERIS CORPORATIONNZA2016-09-08
50724995083774RelianceSTERIS CORPORATIONNZA2016-09-08