Aquanet 4310

GUDID 07540198000114

The Aquanet EC-2000 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for fill

Prime Pacific Health Innovations Corporation

Colonic lavage unit

• Primary Device ID: 07540198000114
• NIH Device Record Key: 14c39988-f4df-4564-bf75-8f67ae93592e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquanet
• Version Model Number: EC-2000
• Catalog Number: 4310
• Company DUNS: 250896255
• Company Name: Prime Pacific Health Innovations 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: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540198000114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000031

FDA Product Code

• KPL: Colonic Irrigation System

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: 2016-09-23

On-Brand Devices [Aquanet]

• 07540198000121: The Aquanet GRY-500 is a colon hydrotherapy device. It introduces water at a comfortable tempera
• 07540198000114: The Aquanet EC-2000 is a colon hydrotherapy device. It introduces water at a comfortable tempera
• 07540198000107: The Aquanet APS-100 is a colon hydrotherapy device. It introduces water at a comfortable tempera