Colonic Irrigation Kit

FDA UDI

Class II (US FDA UDI)

by Transcendencias Comerciales Sl

Identity

Trade Name: Colonic Irrigation Kit FDA UDI
Generic Name: Colonic lavage kit, non-surgical FDA UDI
Device Name: 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 hose and a 2.5 g sachet of lubricant. FDA UDI
Model / Reference: Hydrokit with limiter FDA UDI
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 hose and a 2.5 g sachet of lubricant. FDA UDI

Identifiers

Catalog Number: Z-17 FDA UDI
Primary DI / UDI-DI: B482Z170 FDA UDI
510(k) Number: K131852 FDA UDI
FDA Product Code: KPL FDA UDI
GMDN Term: Colonic lavage kit, non-surgical FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5220 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Colonic lavage kit, non-surgical

Colonic Irrigation Kit by Transcendencias Comerciales Sl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Colonic lavage kit, non-surgical.

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Pro-Fit — Prime Pacific Health Innovations Corporation · Class I
QMS - 42SBST — QUALITY MEDICAL SUPPLY, INC. · Class I
QMS - 48CFSP — QUALITY MEDICAL SUPPLY, INC. · Class I
Speculum, Rectal Kit — CLEARWATER COLON HYDROTHERAPY, INC. · Class I
Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
Speculum, Rectal Kit — CLEARWATER COLON HYDROTHERAPY, INC. · Class I
Colonic Irrigation Kit — CLEARWATER COLON HYDROTHERAPY, INC. · Class II

Cleared under the same submission

K131852 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Transcendencias Comerciales Sl

Sources (1)

FDA UDI 530589e2-175e-4324-99e4-a21db52cbb62 36 fields · synced Jun 1, 2026