Identity
- Trade Name
- QMS - AQUA CLEANSE FDA UDI
- Generic Name
- Colonic lavage unit FDA UDI
- Device Name
- AQUA CLEANSE COLON IRRIGATION DEVICE FDA UDI
- Model / Reference
- 01 FDA UDI
- Description
- AQUA CLEANSE COLON IRRIGATION DEVICE FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850014947163 FDA UDI
- 510(k) Number
- K150381 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
Yes
FDA UDI
Category: Colonic lavage unit
Qms - Aqua Cleanse by Quality Medical Supply, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colonic lavage unit.
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- Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SL · Class II
- Aquanet — Prime Pacific Health Innovations Corporation · Class II
- Colonic Lavage Unit — TRANSCENDENCIAS COMERCIALES SL · Class II
- Aquanet — Prime Pacific Health Innovations Corporation · Class II
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
- Quality Medical Supply, Inc.
Sources (1)
- FDA UDI 31237189-2ef5-4428-9913-d6f980930951 35 fields · synced Jun 8, 2026