Colonic Irrigation Kit

Basic Information

• Brand Name: Colonic Irrigation Kit
• Primary DI: B482Z160
• Version / Model: Segmented Hose / Hydrokit with limiter
• Catalog Number: Z-16
• Company Name: TRANSCENDENCIAS COMERCIALES SL
• Labeler DUNS: 562820084
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 7
• Public Version Date: 2022-11-24
• Public Version Status: Update
• Public Device Record Key: b378df94-a70d-4f9e-b2fd-adad704977f2

Device Description

Colon Hydrotherapy Disposable Single-Use Kit, consisting of a large size Bulb Style Speculum with limiter and Obturator, a water inflow tube, a collapsible waste segmented hose and a 2.5 g sachet of lubricant.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
KPL	Colonic Irrigation System	Gastroenterology, Urology	876.5220	2

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
Package	B482Z161	HIBCC	Box	75	In Commercial Distribution
Primary	B482Z160	HIBCC
Package	B482Z162	HIBCC	Box	100	In Commercial Distribution	2222-11-04

Premarket Submissions

Submission Number	Supplement Number
K131852	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid sunlight
• Type: Storage Environment Temperature
• Temperature Range: – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry