Pure-Vu EVS COLON KIT, 5 Pack PV-COL-04-1

GUDID 05060513700410

Pure-Vu EVS Disposable Colon Kit for use with the Pure-Vu System. (5 Pack)

MOTUS GI MEDICAL TECHNOLOGIES LTD

Colonic lavage system, powered-flow

• Primary Device ID: 05060513700410
• NIH Device Record Key: c073c7bc-8660-4fc0-a877-08214e3fddc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure-Vu EVS COLON KIT, 5 Pack
• Version Model Number: PV-COL-04-1
• Catalog Number: PV-COL-04-1
• Company DUNS: 532775983
• Company Name: MOTUS GI MEDICAL TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060513700410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220007

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-10
• Device Publish Date: 2023-11-02

Devices Manufactured by MOTUS GI MEDICAL TECHNOLOGIES LTD

• 05060513700397 - Pure-Vu EVS GASTRO KIT 5 Pack: 2023-11-10 Pure-Vu EVS GASTRO DISPOSABLE KIT 5 Pack
• 05060513700403 - Pure-Vu EVS GASTRO KIT, Single Pack: 2023-11-10 Pure-Vu EVS GASTRO DISPOSABLE KIT, Single Pack
• 05060513700410 - Pure-Vu EVS COLON KIT, 5 Pack: 2023-11-10Pure-Vu EVS Disposable Colon Kit for use with the Pure-Vu System. (5 Pack)
• 05060513700410 - Pure-Vu EVS COLON KIT, 5 Pack: 2023-11-10 Pure-Vu EVS Disposable Colon Kit for use with the Pure-Vu System. (5 Pack)
• 05060513700427 - Pure-Vu EVS Colon Kit, Single Pack: 2023-11-10 Pure-Vu EVS DISPOSABLE COLON KIT for use with the Pure-Vu System.
• 05060513700144 - Pure-Vu EVS System Disposable: 2023-09-14 EVS Disposable Colon Pack (5)
• 05060513700151 - Pure-Vu EVS System: 2023-09-14 (1) EVS Workstation with foot pedal
• 05060513700168 - MOTUS GI Endoscopy Cart (Accessory): 2023-09-14 Endoscopy Cart Accessory used with the MOTUS GI Workstation
• 05060513700199 - Pure-Vu EVS Waste Bag (Accessory): 2023-09-14 EVS Waste Bag (Accessory)