SYSTEM 1E Liquid Chemical Sterilant Processing System - Reworked Placement Progr 7500

GUDID 00724995094225

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.

Corporation Steris Canada

Liquid sterilant sterilizer

• Primary Device ID: 00724995094225
• NIH Device Record Key: 28cc3374-5278-4bf7-9a6f-862cd1c3ff2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SYSTEM 1E Liquid Chemical Sterilant Processing System - Reworked Placement Progr
• Version Model Number: 1E
• Catalog Number: 7500
• Company DUNS: 202659140
• Company Name: Corporation Steris Canada
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995094225 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090036

FDA Product Code

• MED: Sterilant, medical devices

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-12-18
• Device Publish Date: 2016-09-13

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• 00724995217433 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217440 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217457 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217464 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217471 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a
• 00724995217488 - enspire: 2024-04-25 The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and a