AccessGUDID - DEVICE: Speculum, Rectal Kit (B424922478C1)

GUDID

Device Identifier (DI) Information

Brand Name: Speculum, Rectal Kit
Version or Model: SPO2 Small Bulb 1448 G-Hose
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 922478C1
Company Name: CLEARWATER COLON HYDROTHERAPY, INC.

Primary DI Number: B424922478C1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 942667882 *Terms of Use

Device Description: Speculum, Rectal Bulb Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 922478C1 (Class I Device)

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):	No
Over the Counter (OTC):	Yes
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
FFQ	Speculum, Rectal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: Stored in Room Temperature

Clinically Relevant Size

[?]

Size Type Text
Length: 5 Inch

Device Record Status

Public Device Record Key: 7da72c6c-4660-4bc7-9288-db1a1e292995
Public Version Date: October 22, 2018
Public Version Number: 3
DI Record Publish Date: September 05, 2017