DEVICE: Aquanet (07540198000107)

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Device Identifier (DI) Information

Aquanet
APS-100
4305
Prime Pacific Health Innovations Corporation
07540198000107
GS1
1
The Aquanet APS-100 is a colon hydrotherapy device. It introduces water at a comfortable temperature into the large intestine. It is a system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Colonic lavage unit A mains electricity (AC-powered) device designed for semi-automated irrigation, washing, and evacuation of debris from the colon (e.g., faeces, mucous, old cells) primarily for therapeutic applications (e.g., chronic constipation). It consists of an electromechanical unit that regulates flow from a pressurized water supply (i.e., tap water), and typically contains water heating elements, temperature controls, and an operating display. It is connected to a tube that is placed in the patient's rectum enabling warm water to irrigate the colon; it is not designed for automated removal of waste (i.e., open system). It is intended to be operated by a healthcare provider in a clinical setting.
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FDA Product Code

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Product Code Product Code Name
KPL Colonic Irrigation System
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Secondary DI

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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