Identity
- Trade Name
- AquaA FDA UDI
- Generic Name
- Reverse-osmosis water purification system FDA UDI
- Device Name
- Additional membrane filtration unit for AquaA water purification system. AquaA2 1000 for: AquaA 2000 & AquaA2 1000 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 1000 FDA UDI
- Description
- Additional membrane filtration unit for AquaA water purification system. AquaA2 1000 for: AquaA 2000 & AquaA2 1000 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
- 04251285200395 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
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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
- VIVONIC GmbH
Sources (1)
- FDA UDI ddd8dec3-e9e4-4ccc-af7d-118f4f52a185 34 fields · synced May 30, 2026