Colonic Irrigation Kit 924448

GUDID B424924448

Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, California Proposition 65 Material Compliant, Phthalates & DE

CLEARWATER COLON HYDROTHERAPY, INC.

Colonic lavage kit, non-surgical

• Primary Device ID: B424924448
• NIH Device Record Key: 17d4bd4a-8eb7-47e2-bbde-f4c9cce06afe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Colonic Irrigation Kit
• Version Model Number: SP01 Large Bulb 1448
• Catalog Number: 924448
• Company DUNS: 942667882
• Company Name: CLEARWATER COLON HYDROTHERAPY, INC.
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com
• Phone: 352-401-0303
• Email: sales@colonhydrotherapy.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B424924448 [Package]; Contains: B4249244480; Package: Plastic Bag [1 Units]; In Commercial Distribution
HIBCC	B4249244480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000388

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: 4
• Public Version Date: 2018-10-22
• Device Publish Date: 2016-09-24

On-Brand Devices [Colonic Irrigation Kit]

• B424924448: Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, Califor
• B424924442: Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, Califor
• B424923448: Straight Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, Cal
• B424923442: Straight Style Large Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, Cal
• B424922448: Bulb Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, Califor
• B424922442: Bulb Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, Califor
• B424921448: Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, Cal
• B424921442: Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, Cal