Colonic Lavage Unit HC-1

GUDID B482HC11

Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit t

TRANSCENDENCIAS COMERCIALES SL

Colonic lavage unit Colonic lavage unit

• Primary Device ID: B482HC11
• NIH Device Record Key: 1403ceb9-26c9-4c1e-9a18-79846a75bac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colonic Lavage Unit
• Version Model Number: HC-1
• Catalog Number: HC-1
• Company DUNS: 562820084
• Company Name: TRANSCENDENCIAS COMERCIALES SL
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B482HC10 [Primary]
HIBCC	B482HC11 [Package]; Contains: B482HC10; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131852

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: 2016-12-29

On-Brand Devices [Colonic Lavage Unit]

• B482HC2000C1: Colonic Hydroteraphy machine designed for semi-automatic irrigation, washing, and evacuation of
• B482HC1C1: Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris f
• B482HC11: Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris f