Pure-Vu PV-OSK-001

GUDID 05060513700090

(1) Oversleeve

MOTUS GI MEDICAL TECHNOLOGIES LTD

Colonic lavage system, powered-flow

• Primary Device ID: 05060513700090
• NIH Device Record Key: 50286f51-1028-4aca-a54b-9d7e685e1638
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure-Vu
• Version Model Number: PV-OSK-001
• Catalog Number: PV-OSK-001
• Company DUNS: 532775983
• Company Name: MOTUS GI MEDICAL TECHNOLOGIES LTD
• 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: true
• 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: 888-438-9996
• Email: customer@motusgi.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0 KiloPascal and 81 KiloPascal
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060513700045 [Primary]
GS1	05060513700090 [Package]; Contains: 05060513700045; Package: Large Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160015

FDA Product Code

• FDF: Colonoscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-03

On-Brand Devices [Pure-Vu]

• 05060513700120: (1) Slim Oversleeve individually packaged
• 05060513700113: (5) Slim Oversleeves individually packaged
• 05060513700076: (1) Workstation connector individually packaged
• 05060513700083: (1) Workstation connector
• 05060513700052: (1) Oversleeve individually packaged
• 05060513700090: (1) Oversleeve
• 05060513700038: (1) Loading fixture & (1) Unloading fixture with sealing plugs
• 05060513700021: (1) Unloading fixture with sealing plug
• 05060513700014: (1) Loading fixture with sealing plug
• 05060513700007: (1) Workstation with foot pedal