AccessGUDID - DEVICE: Colon Cleansing Nozzle with Flex Tube (B149SP0001)

GUDID

Device Identifier (DI) Information

Brand Name: Colon Cleansing Nozzle with Flex Tube
Version or Model: SP0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP0001
Company Name: LIFESTREAM PURIFICATION SYSTEM LLC

Primary DI Number: B149SP0001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 005549337 *Terms of Use

Device Description: Colon Cleansing Nozzle with Flex Tube

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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?
48009	Colonic lavage nozzle, sterile	A sterile, hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system or a colonic irrigation unit. It is typically designed as a one-piece, moulded nozzle that may have a slight bulb shape at the distal end to improve retention in the rectum and a barbed fitting at the proximal end for the attachment of the irrigation fluid tubing. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KPL	Colonic Irrigation System

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6ff07f20-dde0-41b6-a644-26a327be7da8
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: February 10, 2017