Identity
- Trade Name
- Visual LED Indicator FDA UDI
- Generic Name
- Reverse-osmosis water purification system FDA UDI
- Device Name
- The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g. the reverse osmosis water treatment system). The status of a connected device is signaled: – Visually by three indicator lights (green, yellow, and red) – Acoustically by a sound generator An acoustic status signal can be muted temporarily at the touch of a button. The signaling device can currently be operated with the following reverse osmosis systems from Fresenius: – AquaA – AquaBplus FDA UDI
- Model / Reference
- - FDA UDI
- Description
- The Visual LED Indicator is used to remotely monitor the operating status of a connected device (e.g. the reverse osmosis water treatment system). The status of a connected device is signaled: – Visually by three indicator lights (green, yellow, and red) – Acoustically by a sound generator An acoustic status signal can be muted temporarily at the touch of a button. The signaling device can currently be operated with the following reverse osmosis systems from Fresenius: – AquaA – AquaBplus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251285200500 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
Yes
FDA UDI
Category: Reverse-osmosis water purification system
Visual LED Indicator by VIVONIC GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Reverse-osmosis water purification system.
- 2436RO, 12600GPD, 230V, 7MEM — Better Water, Inc. · Class II
- BioPure HX2 — MAR COR PURIFICATION, INC. · Class II
- 23 G — MAR COR PURIFICATION, INC. · Class II
- Millenium — MAR COR PURIFICATION, INC. · Class II
- AmeriWater MediQA 00MSP1-230 — AMERIWATER LLC. · Class II
- BioPure 4400 RO — MAR COR PURIFICATION, INC. · Class II
- BioPure 4400 RO — MAR COR PURIFICATION, INC. · Class II
- BioPure HX2 — Biolab Equipment Ltd · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VIVONIC GmbH
Sources (1)
- FDA UDI 66057577-b9b9-44b0-881a-fae3e7276b7d 34 fields · synced May 30, 2026