FDA UDI
In Commercial Distribution
🇺🇸 United States
Colonic Lavage System
DI: B4244001010
·
Model: PPC-101 Clinical
·
CLEARWATER COLON HYDROTHERAPY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Colonic Lavage System
- Primary DI
- B4244001010
- Version / Model
- PPC-101 Clinical
- Catalog Number
- 400101
- Company Name
- CLEARWATER COLON HYDROTHERAPY, INC.
- Labeler DUNS
- 942667882
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 19a8730d-4ac9-4082-96da-a20466121ad6
Device Description
PPC-101 Clinical Model/U.V. Filter System CCH Part No. 400101
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Package | B424400101 | HIBCC | Wood Crate | 1 | In Commercial Distribution | |
| Primary | B4244001010 | HIBCC |
Customer Contacts
- Phone
- 352-401-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K942867 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stored in Room Temperature