FDA UDI
In Commercial Distribution
🇺🇸 United States
Colon Cleansing Nozzle with Flex Tube
DI: B149SP0001
·
Model: SP0001
·
LIFESTREAM PURIFICATION SYSTEM LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
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Basic Information
- Brand Name
- Colon Cleansing Nozzle with Flex Tube
- Primary DI
- B149SP0001
- Version / Model
- SP0001
- Catalog Number
- SP0001
- Company Name
- LIFESTREAM PURIFICATION SYSTEM LLC
- Labeler DUNS
- 005549337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2017-02-10
- Public Version
- 3
- Public Version Date
- 2018-08-09
- Public Version Status
- Update
- Public Device Record Key
- 6ff07f20-dde0-41b6-a644-26a327be7da8
Device Description
Colon Cleansing Nozzle with Flex Tube
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 48009 | Colonic lavage nozzle, sterile | A sterile, hollow cylinder intended to be inserted into the rectum for the administration of irrigation fluid from a connected colonic lavage system or a colonic irrigation unit. It is typically designed as a one-piece, moulded nozzle that may have a slight bulb shape at the distal end to improve retention in the rectum and a barbed fitting at the proximal end for the attachment of the irrigation fluid tubing. It may be designed for open (entry of fluid only) or closed (entry of fluid and evacuation of waste), and clinical or home-use, colonic lavage. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | B149SP00011 | HIBCC | Box | 50 | ||
| Primary | B149SP0001 | HIBCC | ||||
| Unit of Use | SP00010 | HIBCC |
Customer Contacts
- Phone
- 5127078383
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 90 Degrees Fahrenheit