Identity
- Trade Name
- AquaA FDA UDI
- Generic Name
- Reverse-osmosis water purification system FDA UDI
- Device Name
- Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system. AquaA2 2700H for: AquaA 2700H & AquaA2 2700H AquaA 2700H & AquaA2 2700H & AquaHT The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards. FDA UDI
- Model / Reference
- AquaA2 2700H FDA UDI
- Description
- Additional membrane filtration unit (heat-disinfectable) for AquaA water purification system. AquaA2 2700H for: AquaA 2700H & AquaA2 2700H AquaA 2700H & AquaA2 2700H & AquaHT The AquaA water purification system is a modular reverse osmosis unit intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or related therapies. This device is intended to be a component in a complete water purification system and is not a complete water treatment system. The reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (U.S.) standards. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251285200456 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
AquaA 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 acf54d86-53c1-4ce8-8854-a3ec361ec2ed 34 fields · synced May 30, 2026