Speculum, Rectal Kit

Basic Information

• Brand Name: Speculum, Rectal Kit
• Primary DI: B424924648
• Version / Model: SPO1 Large Bulb 3848 G-Hose
• Catalog Number: 924648
• Company Name: CLEARWATER COLON HYDROTHERAPY, INC.
• Labeler DUNS: 942667882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-05
• Public Version: 3
• Public Version Date: 2018-10-22
• Public Version Status: Update
• Public Device Record Key: 1a09e337-ea62-4b17-8250-ec1fc6d5f096

Device Description

Speculum, Rectal Bulb Style Large Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 924648 (Class I Device)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FFQ	Speculum, Rectal	Gastroenterology, Urology	876.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60903	Colonic lavage kit, non-surgical	A collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B424924648	HIBCC
Package	B4249246480	HIBCC	Plastic Bag	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	6	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stored in Room Condition