Home GUDID B149SP00011
Colon Cleansing Nozzle with Flex Tube
Primary DI B149SP00011
Brand Colon Cleansing Nozzle with Flex Tube
Company LIFESTREAM PURIFICATION SYSTEM LLC
Model SP0001
Catalog number SP0001
Device description Colon Cleansing Nozzle with Flex Tube
Published 2017-02-10
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name KPL Colonic Irrigation System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KPL Colonic Irrigation System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B149SP00011 Package HIBCC 50 B149SP0001 Primary HIBCC 0 SP00010 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 50 Degrees Fahrenheit 90 Degrees Fahrenheit
Regulatory Flags# DUNS number 005549337 Device count 50 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B149CM11 Angel of Water CM-1 2023-12-11 B149SP0001 Colon Cleansing Nozzle with Flex Tube SP0001 SP0001 2017-02-10
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published B149CM11 Angel of Water LIFESTREAM PURIFICATION SYSTEM LLC KPL 2023-12-11 00868538000417 LIBBE Colonic Nozzle Mind Body Naturopathic Inst KPL 2021-04-30 10868538000414 LIBBE Colonic Nozzle Mind Body Naturopathic Inst KPL 2021-04-30 00850014947163 QMS - AQUA CLEANSE QUALITY MEDICAL SUPPLY, INC. KPL 2019-12-12 00868538000400 LIBBE Colon Hydrotherapy System Mind Body Naturopathic Inst KPL 2017-12-29 B149SP0001 Colon Cleansing Nozzle with Flex Tube LIFESTREAM PURIFICATION SYSTEM LLC KPL 2017-02-10 B482HC10 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC1C0 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC2000C0 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z090 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z100 Colonic irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z160 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z170 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z200 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC11 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC1C1 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482HC2000C1 Colonic Lavage Unit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z091 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z101 Colonic irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z161 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z171 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B482Z201 Colonic Irrigation Kit TRANSCENDENCIAS COMERCIALES SL KPL 2016-12-29 B4244001010 Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4244001510 Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4244002010 Colonic Lavage System CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247201000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247202000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247203000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4247204000 Colonic Irrigation Nozzle CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24 B4249214420 Colonic Irrigation Kit CLEARWATER COLON HYDROTHERAPY, INC. KPL 2016-09-24