Acu-SinQ AQSCOMP

GUDID 00724995167745

The Acu-SinQ Complete Endoscope Cleaning Aid System is designed to provide support for automated leak testing, dosing, temperature monitoring, channel flushing, rinsing, and process documentation.

US Endoscopy

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• Primary Device ID: 00724995167745
• NIH Device Record Key: add77ea6-7bc8-400e-b913-c0ce00af6263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acu-SinQ
• Version Model Number: Acu-SinQ Complete
• Catalog Number: AQSCOMP
• Company DUNS: 627879687
• Company Name: US Endoscopy
• 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)769-8226
• Email: global@usendoscopy.com
• Phone: +1(800)548-4873
• Email: xx@xx.xx
• Phone: +1(800)548-4873
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00724995167745 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181865

FDA Product Code

• FEB: Accessories, cleaning, for endoscope

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: 2019-03-11
• Device Publish Date: 2019-02-28

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