Speculum Rectal 720300C1

GUDID B4247203000C1

Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720300C1 (Class I Device

CLEARWATER COLON HYDROTHERAPY, INC.

Colonic lavage kit, non-surgical

• Primary Device ID: B4247203000C1
• NIH Device Record Key: c662fbb6-38f5-4869-8e60-a7ff2a15bf02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speculum Rectal
• Version Model Number: SPO1 Large Straight Speculum
• Catalog Number: 720300C1
• 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 Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Stored in Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B4247203000C1 [Package]; Contains: B424720300C1; Package: Plastic Bag [1 Units]; In Commercial Distribution
HIBCC	B424720300C1 [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

Devices Manufactured by CLEARWATER COLON HYDROTHERAPY, INC.

• B4247201000C1 - Speculum, Rectal: 2018-10-22 Speculum, Rectal Straight Style Small ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720
• B4247202000C1 - Speculum, Rectal: 2018-10-22 Speculum, Rectal Bulb Style Small ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720200C
• B4247203000C1 - Speculum Rectal: 2018-10-22Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720300C1 (Class I Device
• B4247203000C1 - Speculum Rectal: 2018-10-22 Speculum, Rectal Straight Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720
• B4247204000C1 - Speculum, Rectal: 2018-10-22 Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720400C
• B424921442 - Colonic Irrigation Kit: 2018-10-22 Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 42 waste hose~5g surgical lube packet, California Proposition 65 Material
• B424921448 - Colonic Irrigation Kit: 2018-10-22 Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose~5g surgical lube packet, California Proposition 65 Material
• B424921478C1 - Speculum, Rectal Kit: 2018-10-22 Speculum, Rectal Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, Califor
• B424921648 - Speculum, Rectal Kit: 2018-10-22 Speculum, Rectal Straight Style Small Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, Califor