Identity
- Trade Name
- Angel of Water FDA UDI
- Generic Name
- Colonic lavage system, gravity-flow FDA UDI
- Device Name
- Colon Irrigation Device FDA UDI
- Model / Reference
- CM-1 FDA UDI
- Description
- Colon Irrigation Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- B149CM11 FDA UDI
- 510(k) Number
- K003720 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Colonic lavage system, gravity-flow
Angel of Water by Lifestream Purification System Llc — 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
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- 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
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
- Lifestream Purification System Llc
Sources (1)
- FDA UDI af4bd1a2-5e11-46f6-9b8a-e7a3af3e808c 35 fields · synced Jun 8, 2026