enspire ENHLD300480VFD

GUDID 00724995217471

The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, high level disinfect, rinse and air purge up to two heat-sensitive, immersible, reusable, semi-critical devices including, but not limited to, GI flexible endoscopes such as bronchoscopes, gastroscopes, and duodenoscopes; or up to six non-channeled naso-endoscopes.

Corporation Steris Canada

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• Primary Device ID: 00724995217471
• NIH Device Record Key: e537c10f-14a6-413d-acef-708669e6fa34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enspire
• Version Model Number: enspire 300 Series
• Catalog Number: ENHLD300480VFD
• 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: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995217471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230560

FDA Product Code

• MED: Sterilant, medical devices

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

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• 00724995217495: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h
• 00724995217488: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h
• 00724995217471: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h
• 00724995217464: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h
• 00724995217457: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h
• 00724995217440: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h
• 00724995217433: The enspire 300 Series Automated Endoscope Reprocessor is designed to effectively test, clean, h