Identity
- Trade Name
- MEDIPAC, 2880GPD, DIRECT FEED, 115V FDA UDI
- Generic Name
- Combination water purification system FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- EQMEDIPAC-2880-DF-10 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- EQMEDIPAC-2880-DF-10 FDA UDI
- Primary DI / UDI-DI
- MP0001 FDA UDI
- 510(k) Number
- K920186 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Combination water purification system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Combination water purification system
Medipac, 2880gpd, Direct Feed, 115v by Better Water, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Combination water purification system.
- Brine Tank — SPECIALITY WATER TECHNOLOGY · Class II
- Softener Tank — SPECIALITY WATER TECHNOLOGY · Class II
- Softener Tank — SPECIALITY WATER TECHNOLOGY · Class II
- De-Alkalizer — SPECIALITY WATER TECHNOLOGY · Class II
- HistoSonics — HISTOSONICS, INC · Class I
- HistoSonics — HISTOSONICS, INC
- Organic Scavenger — SPECIALITY WATER TECHNOLOGY · Class II
- Softener Tank — SPECIALITY WATER TECHNOLOGY · Class II
Cleared under the same submission
K920186 also covers:
- 1232RO, 2880GPD, 120V, 4MEM — Better Water, Inc.
- 2020RO, 3600GPD, 208V, 2MEM — Better Water, Inc.
- 2020RO, 3600GPD, 230V, 2MEM — Better Water, Inc.
- 2020RO, 3600GPD, 460V, 2MEM — Better Water, Inc.
- 2020RO, 5400GPD, 208V, 3MEM — Better Water, Inc.
- 2020RO, 5400GPD, 230V, 3MEM — Better Water, Inc.
- 2436RO, 10800GPD, 208V, 6MEM — Better Water, Inc.
- 2436RO, 10800GPD, 230V, 6MEM — Better Water, Inc.
- 2436RO, 10800GPD, 460V, 6MEM — Better Water, Inc.
- 2436RO, 12600GPD, 208V, 7MEM — Better Water, Inc.
- 2436RO, 12600GPD, 230V, 7MEM — Better Water, Inc.
- 2436RO, 12600GPD, 460V, 7MEM — Better Water, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Better Water, Inc.
Sources (1)
- FDA UDI 199f44fe-308f-4ae7-9741-91a2b240ba48 35 fields · synced Jun 6, 2026