Identity
- Trade Name
- Aquanet FDA UDI
- Generic Name
- Colonic lavage unit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- APS-100 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 4305 FDA UDI
- Primary DI / UDI-DI
- 07540198000107 FDA UDI
- 510(k) Number
- K000031 FDA UDI
- FDA Product Code
- KPL FDA UDI
- GMDN Term
- Colonic lavage unit 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 unit
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 unit.
- QMS - AQUA CLEANSE — QUALITY MEDICAL SUPPLY, INC. · Class II
- Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SL · Class II
- Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SL · Class II
- Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SL · Class II
- Aquanet — Prime Pacific Health Innovations Corporation · 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 d062a5e1-831a-4af9-874c-44bff3bf465a 35 fields · synced Jun 8, 2026