FDA.reportPublic FDA data

Reliance

Primary DI
00724995152178
Brand
Reliance
Company
Corporation Steris Canada
Model
EPS
Catalog number
MB3
Device description
The Reliance EPS Processor is intended for washing and high Level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes, bronchoscopes and their accessories.
Published
2016-09-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00724995152178PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995152178007249951521787249951521780724995152178

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope washer/disinfectorA mains electricity (AC-powered) unit intended to be used for the washing and/or disinfecting of endoscopes with water or an appropriate disinfectant solution. It has built-in features to circulate a solution through the lumen (flushing) of the endoscope; some types may also have built-in drying features.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
202659140
Device count
1
Serial number
true
Manufacturing date on label
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
00724995087913NACorporation Steris CanadaNZA2016-09-13
00724995087920NACorporation Steris CanadaNZA2016-09-13
00724995090630NACorporation Steris CanadaNZA2016-09-13
10724995083776RelianceSTERIS CORPORATIONNZA2016-09-08
50724995083774RelianceSTERIS CORPORATIONNZA2016-09-08