QPC1802E

GUDID 00724995226725

The Quick Connect Pentax GI Endoscopes is used with C1160E Universal Flexible Processing Tray in the SYSTEM 1E and/or SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems.

STERIS CORPORATION

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• Primary Device ID: 00724995226725
• NIH Device Record Key: 309cc0d6-97bd-4427-bccd-39c6892e9543
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: Quick Connect
• Catalog Number: QPC1802E
• Company DUNS: 868205779
• Company Name: STERIS CORPORATION
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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	00724995226725 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-30
• Device Publish Date: 2023-11-22

Devices Manufactured by STERIS CORPORATION

• 50724995216905 - Revital-Ox: 2024-04-25 Revital-Ox PAA HLD Solution Part B is used Revital-Ox PAA HLD Part A and the enspire 300 Series Automated Endoscope Reprocessor
• 50724995216929 - Revital-Ox: 2024-04-25 Revital-Ox PAA HLD Solution Part A is used Revital-Ox PAA HLD Part B and the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217587 - NA: 2024-04-25 enspire 300 Connector Olympus Channel Separator is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217594 - NA: 2024-04-25 enspire 300 Connector Olympus Channel Separator is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217600 - NA: 2024-04-25 enspire 300 Connector Olympus Air Water Valve is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217617 - NA: 2024-04-25 enspire 300 Connector Olympus Air Water Valve is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217624 - NA: 2024-04-25 enspire 300 Connector Olympus Suction Valve is used with the enspire 300 Series Automated Endoscope Reprocessor
• 00724995217631 - NA: 2024-04-25 enspire 300 Connector Olympus Suction Valve is used with the enspire 300 Series Automated Endoscope Reprocessor