Home GUDID B424922648 Speculum, Rectal Kit
Primary DI B424922648
Brand Speculum, Rectal Kit
Company CLEARWATER COLON HYDROTHERAPY, INC.
Model SPO2 Small Bulb 3848 G-Hose
Catalog number 922648
Device description Speculum, Rectal Bulb Style Small Speculum Kit ~ 3/8 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 922648 (Class I Device)
Published 2017-09-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
Single use true Product Codes# Code, Name table Code Name FFQ Speculum, Rectal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FFQ Speculum, Rectal Gastroenterology, Urology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B4249226480 Package HIBCC 1 In Commercial Distribution B424922648 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Length 5 Inch
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 Stored in Room Condition
Regulatory Flags# DUNS number 942667882 Device count 1 DM exempt true Premarket exempt true Kit true Lot or batch true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B4247201000 Colonic Irrigation Nozzle SP02 Small Straight Speculum 720100 2016-09-24 B4247202000 Colonic Irrigation Nozzle SP02 Small Bulb Speculum 720200 2016-09-24 B4247203000 Colonic Irrigation Nozzle SP01 Large Straight Speculum 720300 2016-09-24 B4247204000 Colonic Irrigation Nozzle SP01 Large Bulb Speculum 720400 2016-09-24 B424720100C1 Speculum, Rectal SPO2 Small Straight Speculum 720100C1 2017-09-05 B424720200C1 Speculum, Rectal SPO2 Small Bulb Speculum 720200C1 2017-09-05 B424720300C1 Speculum Rectal SPO1 Large Straight Speculum 720300C1 2017-09-05 B424720400C1 Speculum, Rectal SPO1 Large Bulb Speculum 720400C1 2017-09-05 B4249214420 Colonic Irrigation Kit SP02 Small Straight 1442 921442 2016-09-24 B4249214480 Colonic Irrigation Kit SP02 Small Straight 1448 921448 2016-09-24 B4249224420 Colonic Irrigation Kit SP02 Small Bulb 1442 922442 2016-09-24 B4249224480 Colonic Irrigation Kit SP02 Small Bulb 1448 922448 2016-09-24 B4249234420 Colonic Irrigation Kit SP01 Large Straight 1442 923442 2016-09-24 B4249234480 Colonic Irrigation Kit SP01 Large Straight 1448 923448 2016-09-24 B4249244420 Colonic Irrigation Kit SP01 Large Bulb 1442 924442 2016-09-24 B4249244480 Colonic Irrigation Kit SP01 Large Bulb 1448 924448 2016-09-24 B4247201000C1 Speculum, Rectal SPO2 Small Straight Speculum 720100C1 2017-09-05 B4247202000C1 Speculum, Rectal SPO2 Small Bulb Speculum 720200C1 2017-09-05 B4247203000C1 Speculum Rectal SPO1 Large Straight Speculum 720300C1 2017-09-05 B4247204000C1 Speculum, Rectal SPO1 Large Bulb Speculum 720400C1 2017-09-05
Other Devices Sharing Product Codes# 
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