FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDIPAC, 2880GPD, DIRECT FEED, 115V
DI: MP0001
·
Model: EQMEDIPAC-2880-DF-10
·
BETTER WATER, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDIPAC, 2880GPD, DIRECT FEED, 115V
- Primary DI
- MP0001
- Version / Model
- EQMEDIPAC-2880-DF-10
- Catalog Number
- EQMEDIPAC-2880-DF-10
- Company Name
- BETTER WATER, LLC
- Labeler DUNS
- 055252159
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-13
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 199f44fe-308f-4ae7-9741-91a2b240ba48
Device Description
Complete water purification system on a single platform with casters for dialysis applications. Direct-feed, 2880 gallons per day, 115V. Includes the following components: - Pretreatment: carbon media tanks (carbon & polisher), water softener (tank and brine tank), particulate filtration, and UV light. - Reverse Osmosis device: 1232 series - Posttreatment: particulate filtration, and UV light - Other: disinfect tank
Device Characteristics
- Single Use
- No
- 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
- 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 | MP0001 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K920186 | 000 |