FDA UDI
In Commercial Distribution
🇺🇸 United States
Water Purification System for Hemodialysis
DI: 00860006352127
·
Model: Complete System
·
Nelson Environmental Technologies Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Water Purification System for Hemodialysis
- Primary DI
- 00860006352127
- Version / Model
- Complete System
- Company Name
- Nelson Environmental Technologies Inc
- Labeler DUNS
- 835316464
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-17
- Public Version
- 1
- Public Version Date
- 2023-08-25
- Public Version Status
- New
- Public Device Record Key
- 8a21db4a-5c67-42a0-87e7-8da6994ea1b1
Device Description
Nelson Water System's Water Purification System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water.
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 |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44344 | Combination water purification system | An assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860006352127 | GS1 |