Speculum, Rectal 720400C1

GUDID B4247204000C1

Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720400C1 (Class I Device)

CLEARWATER COLON HYDROTHERAPY, INC.

Colonic lavage kit, non-surgical Colonic lavage kit, non-surgical

• Primary Device ID: B4247204000C1
• NIH Device Record Key: d7365d49-9a38-4fc8-8a40-99262331c3bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speculum, Rectal
• Version Model Number: SPO1 Large Bulb Speculum
• Catalog Number: 720400C1
• Company DUNS: 942667882
• Company Name: CLEARWATER COLON HYDROTHERAPY, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

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

Device Dimensions

• Length: 6 Inch
• Length: 6 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4247204000C1 [Package]; Contains: B424720400C1; Package: Plastic Bag [1 Units]; In Commercial Distribution
HIBCC	B424720400C1 [Primary]

FDA Product Code

• FFQ: Speculum, Rectal

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: 2018-10-22
• Device Publish Date: 2017-09-05

On-Brand Devices [Speculum, Rectal]

• B4247204000C1: Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates &
• B4247202000C1: Speculum, Rectal Bulb Style Small ~ California Proposition 65 material Compliant, Phthalates &
• B4247201000C1: Speculum, Rectal Straight Style Small ~ California Proposition 65 material Compliant, Phthalat