FDA.reportPublic FDA data

SYSTEM 1E Liquid Chemical Sterilant Processing System

Primary DI
00724995092986
Brand
SYSTEM 1E Liquid Chemical Sterilant Processing System
Company
Corporation Steris Canada
Model
1E
Catalog number
6500
Device description
The SYSTEM 1E Liquid Chemical Sterilant Processing System is for safe and effective reprocessing of heat-sensitive critical and semi-critical medical devices.
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
MEDSterilant, medical devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090036000
K101409000
K102462000
K113520000
K131078000
K161683000
K170956000
K180342000
K190104000
K192929000
K210737000
K211607000
K222615000
K232914000
K251666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090036000SYSTEM 1.5 STERILE PROCESSING SYSTEMSTERIS Corporation2010-04-05MED
K101409000SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEMSTERIS Corporation2010-08-02MED
K102462000SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2010-09-21MED
K113520000SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2012-02-21MED
K131078000SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation2013-07-05MED
K161683000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2016-08-05MED
K170956000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2017-09-22MED
K180342000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations2018-04-04MED
K190104000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemSteris Corporations2019-03-22MED
K192929000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2019-12-10MED
K210737000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation2021-05-12MED
K211607000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation2021-09-07MED
K222615000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant ConcentrateSTERIS Corporation2022-09-28MED
K232914000SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800); SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900)STERIS Corporation2023-10-03MED
K251666000SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2026-04-08MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995092986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995092986007249950929867249950929860724995092986

GMDN Terms#

Term, Definition table
TermDefinition
Liquid sterilant sterilizerA mains electricity (AC-powered) device designed for total elimination and/or inactivation of microorganisms from medical devices and related products by immersion in sterilant solutions [e.g., formaldehyde, glutaraldehyde, ortho-phthalaldehyde (OPA) also known as phthaldehyde]; it is typically used for products sensitive to high temperature and humidity and not damaged by sterilant solution. It typically includes a treatment chamber with a container for liquid sterilant and where trays with the devices to be sterilized are manually placed, usually after cleaning of gross debris; a mechanism to introduce and/or circulate the liquid into the chamber; and controls to regulate procedure time.

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
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
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
00724995002619NAFlow Unit 10EPSC010INT2017-04-15

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