FDA UDI
In Commercial Distribution
🇺🇸 United States
Angel of Water
DI: B149CM11
·
Model: CM-1
·
LIFESTREAM PURIFICATION SYSTEM LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Angel of Water
- Primary DI
- B149CM11
- Version / Model
- CM-1
- Company Name
- LIFESTREAM PURIFICATION SYSTEM LLC
- Labeler DUNS
- 005549337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-11
- Public Version
- 1
- Public Version Date
- 2023-12-19
- Public Version Status
- New
- Public Device Record Key
- af4bd1a2-5e11-46f6-9b8a-e7a3af3e808c
Device Description
Colon Irrigation Device
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KPL | Colonic Irrigation System | Gastroenterology, Urology | 876.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43827 | Colonic lavage system, gravity-flow | An assembly of devices designed for the irrigation, washing, and evacuation of debris from the colon. It typically consists of a fluid reservoir, tubing, nozzle, and controls that regulate the temperature and pressure of the gravity-induced water flow from a tap (faucet) and into the rectum. The device may include a console-type toilet and fittings to allow connection to water and sewer pipes for the effluent. The system provides colonic hydrotherapy to remove damaged tissue and/or debris (e.g., faeces, foreign objects) in emergency departments, and to clean/evacuate the colon for endoscopic/surgical procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B149CM11 | HIBCC |
Customer Contacts
- Phone
- 5127078383
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K003720 | 000 |