Home GUDID B4247204000C1 Speculum, Rectal
Primary DI B4247204000C1
Brand Speculum, Rectal
Company CLEARWATER COLON HYDROTHERAPY, INC.
Model SPO1 Large Bulb Speculum
Catalog number 720400C1
Device description Speculum, Rectal Bulb Style Large ~ California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 720400C1 (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
Rx false
OTC true
Sterile false
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 B4247204000C1 Package HIBCC 1 In Commercial Distribution B424720400C1 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 6 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 HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 B424922648 Speculum, Rectal Kit SPO2 Small Bulb 3848 G-Hose 922648 2017-09-05 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
Other Devices Sharing Product Codes# 
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