AccessGUDID - DEVICE: Colonic Irrigation Kit (B482Z200)

GUDID

Device Identifier (DI) Information

Brand Name: Colonic Irrigation Kit
Version or Model: Segmented Hose / Large Hydrokit
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z-20
Company Name: TRANSCENDENCIAS COMERCIALES SL

Primary DI Number: B482Z200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 562820084 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPL	Colonic Irrigation System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131852	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Avoid sunlight
Storage Environment Temperature: less than 35 Degrees Celsius
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 09851938-5ba5-4ce8-b1ea-28893ae2d737
Public Version Date: November 24, 2022
Public Version Number: 7
DI Record Publish Date: December 29, 2016