FDA UDI
In Commercial Distribution
🇺🇸 United States
Colonic Lavage Unit
DI: B482HC1C0
·
Model: HC-1 Classic
·
TRANSCENDENCIAS COMERCIALES SL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Colonic Lavage Unit
- Primary DI
- B482HC1C0
- Version / Model
- HC-1 Classic
- Catalog Number
- HC-1 Classic
- Company Name
- TRANSCENDENCIAS COMERCIALES SL
- Labeler DUNS
- 562820084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-29
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 40244f02-8313-4d12-9db6-c8f32b1afab0
Device Description
Colonic Hydroteraphy machine designed for manual irrigation, washing, and evacuation of debris from the colon. Consists of an electromechanical unit that irrigates sterilised water into the patient´s colon. Flow, pressure and temperature can be regulated from a pressurized water supply (i.e., tap water), and contains pressure and temperature controls. It is a non-portable, wall-fixed machine.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- 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 |
|---|---|---|---|---|
| 58181 | Colonic lavage unit | A mains electricity (AC-powered) device designed for semi-automated irrigation, washing, and evacuation of debris from the colon (e.g., faeces, mucous, old cells) primarily for therapeutic applications (e.g., chronic constipation). It consists of an electromechanical unit that regulates flow from a pressurized water supply (i.e., tap water), and typically contains water heating elements, temperature controls, and an operating display. It is connected to a tube that is placed in the patient's rectum enabling warm water to irrigate the colon; it is not designed for automated removal of waste (i.e., open system). It is intended to be operated by a healthcare provider in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B482HC1C1 | HIBCC | Box | 1 | In Commercial Distribution | |
| Primary | B482HC1C0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131852 | 000 |