FDA UDI
In Commercial Distribution
🇺🇸 United States
Colonic irrigation Kit
DI: B482Z100
·
Model: Small Hydrokit
·
TRANSCENDENCIAS COMERCIALES SL
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Colonic irrigation Kit
- Primary DI
- B482Z100
- Version / Model
- Small Hydrokit
- Catalog Number
- Z-10
- 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
- 7
- Public Version Date
- 2022-11-24
- Public Version Status
- Update
- Public Device Record Key
- 437c99bc-c64a-4db4-8aee-560e6ffa700e
Device Description
Colon Hydrotherapy Disposable Single-Use Kit, consisting of a small size Bulb Style Speculum with Obturator, a water inflow tube, a collapsible waste hose and a 2.5 g sachet of lubricant.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| 60903 | Colonic lavage kit, non-surgical | A collection of non-sterile devices intended to be used with a colonic lavage system/unit for the administration of an irrigation solution (e.g., saline solution) via the rectum, for the non-surgical irrigation, cleansing, and evacuation of debris from the colon. It includes both an inflow tube (intended to facilitate the ingress of fluid into the colon) and a waste tube (intended to transport fluids and waste matter away from the patient), a colonic irrigation nozzle, and may include additional supportive devices (e.g., lubricant, connectors). The kit may also be intended to support enema delivery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B482Z101 | HIBCC | Box | 75 | In Commercial Distribution | |
| Primary | B482Z100 | HIBCC | ||||
| Package | B482Z102 | HIBCC | Box | 100 | In Commercial Distribution | 2222-11-04 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131852 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- – 35 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry