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SYSTEM 1E Liquid Chemical Sterilant Processing System - Reworked Placement Progr

Primary DI
00724995094225
Brand
SYSTEM 1E Liquid Chemical Sterilant Processing System - Reworked Placement Progr
Company
Corporation Steris Canada
Model
1E
Catalog number
7500
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. This unit is distributed through the STERIS Reworked Placement Program.
Published
2016-09-13
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
MEDSterilant, medical devices

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090036000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090036000SYSTEM 1.5 STERILE PROCESSING SYSTEMSTERIS Corporation2010-04-05MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00724995094225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995094225007249950942257249950942250724995094225

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

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Primary DI, Brand, Model table
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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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