Identity
- Trade Name
- 3046RO, 16200GPD, 460V, 9MEM FDA UDI
- Generic Name
- Reverse-osmosis water purification system FDA UDI
- Device Name
- Reverse osmosis device for water purification for dialysis applications. 3046 series, nine membranes, 460V. FDA UDI
- Model / Reference
- EQRMA-3016K-3H FDA UDI
- Description
- Reverse osmosis device for water purification for dialysis applications. 3046 series, nine membranes, 460V. FDA UDI
Identifiers
- Catalog Number
- EQRMA-3016K-3H FDA UDI
- Primary DI / UDI-DI
- RO0304 FDA UDI
- 510(k) Number
- K920186 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Reverse-osmosis 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: Reverse-osmosis water purification system
3046ro, 16200gpd, 460v, 9mem by Better Water, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 fa02615c-2c1c-451b-b7e6-42cf05f924c3 35 fields · synced May 30, 2026