Identity
- Trade Name
- Aquanet FDA UDI
- Generic Name
- Colonic lavage system, gravity-flow FDA UDI
- Device Name
- The Aquanet GRY-500 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. FDA UDI
- Model / Reference
- GRY-500 FDA UDI
- Description
- The Aquanet GRY-500 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. FDA UDI
Identifiers
- Catalog Number
- 4300 FDA UDI
- Primary DI / UDI-DI
- 07540198000121 FDA UDI
- 510(k) Number
- K000031 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Colonic lavage system, gravity-flow FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5220 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colonic lavage system, gravity-flow
Aquanet by Prime Pacific Health Innovations Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colonic lavage system, gravity-flow.
- Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
- Angel of Water — LIFESTREAM PURIFICATION SYSTEM LLC · Class II
- Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
- Colonic Lavage System — CLEARWATER COLON HYDROTHERAPY, INC. · Class II
- LIBBE Colon Hydrotherapy System — Mind Body Naturopathic Inst · Class II
Cleared under the same submission
K000031 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Prime Pacific Health Innovations Corporation
Sources (1)
- FDA UDI 8c9ba451-35dd-4ca9-a7d3-ac5579383fb4 35 fields · synced May 30, 2026