Speculum, Rectal Kit 922478C1

GUDID B424922478C1

Speculum, Rectal Bulb Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 materia

CLEARWATER COLON HYDROTHERAPY, INC.

Colonic lavage kit, non-surgical

• Primary Device ID: B424922478C1
• NIH Device Record Key: 7da72c6c-4660-4bc7-9288-db1a1e292995
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Speculum, Rectal Kit
• Version Model Number: SPO2 Small Bulb 1448 G-Hose
• Catalog Number: 922478C1
• 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: 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: 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: 5 Inch
• Length: 5 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	B4249224780C1 [Package]; Package: Plastic Bag [1 Units]; In Commercial Distribution
HIBCC	B424922478C1 [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 Kit]

• B424924648: Speculum, Rectal Bulb Style Large Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g s
• B424924478C1: Speculum, Rectal Bulb Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g s
• B424923648: Speculum, Rectal Straight Style Large Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~
• B424923478C1: Speculum, Rectal Straight Style Large Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~
• B4249226480: Speculum, Rectal Bulb Style Small Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g s
• B424922478C1: Speculum, Rectal Bulb Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g s
• B424921648: Speculum, Rectal Straight Style Small Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~
• B424921478C1: Speculum, Rectal Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~