FDA UDI
In Commercial Distribution
🇺🇸 United States
Colonic Irrigation Nozzle
DI: B4247202000
·
Model: SP02 Small Bulb Speculum
·
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 Irrigation Nozzle
- Primary DI
- B4247202000
- Version / Model
- SP02 Small Bulb Speculum
- Catalog Number
- 720200
- 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
- 6
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- f40291ce-b195-46fd-bc69-f65927d09b15
Device Description
Small Bulb Speculum with Obturator, California Proposition 65 Material Compliant, Phthalates & DEHP Fee, CCH Part No. 720200
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 14187 | Rectal/colonic irrigation nozzle, single-use | An invasive luminal device intended to be inserted into the rectum and/or colostomy site for the administration of irrigation fluid into the rectum and/or large intestines during a rectal irrigation, colonic lavage, enema, and/or colostomy site irrigation procedure. Available in a variety of designs, it may be referred to as a cone, tip, speculum, or rectal catheter, and may include an inflatable balloon for retention. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B424720200 | HIBCC | Plastic Bag | 1 | In Commercial Distribution | |
| Primary | B4247202000 | HIBCC |
Customer Contacts
- Phone
- 352-401-0303
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K000388 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Stored in Room Temperature