FDA.reportPublic FDA data

NA

Primary DI
00724995157449
Brand
NA
Company
Corporation Steris Canada
Model
C3000XL
Catalog number
C3000XL
Device description
The Ultrasound Processing Tray is used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.
Published
2020-01-02
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
K170956000
K173256000
K180342000
K182827000
K190104000
K191343000
K192929000
K210737000
K211607000
K222615000
K230582000
K232914000
K251666000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170956000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation2017-09-22MED
K173256000System 1 endo Liquid Chemical Sterilant Processing SystemSTERIS Corporation2018-03-02MED
K180342000SYSTEM 1E Liquid Chemical Sterilant Processing SystemSteris Corporations2018-04-04MED
K182827000SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900STERIS Corporation2019-01-31MED
K190104000SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing SystemSteris Corporations2019-03-22MED
K191343000SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900STERIS Corporation2019-09-05MED
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
K230582000SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900STERIS Corporation2023-03-28MED
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
00724995157449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00724995157449007249951574497249951574490724995157449

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

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

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