FDA UDI
In Commercial Distribution
🇺🇸 United States
AquaDETECTOR
DI: 04251285200517
·
Model: -
·
VIVONIC GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AquaDETECTOR
- Primary DI
- 04251285200517
- Version / Model
- -
- Company Name
- VIVONIC GmbH
- Labeler DUNS
- 341685795
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-08
- Public Version
- 1
- Public Version Date
- 2022-08-16
- Public Version Status
- New
- Public Device Record Key
- 8f5101a7-d4ac-487d-8f3c-95a61390593f
Device Description
The AquaDETECTOR leakage monitoring system provides full leakage monitoring of a dialysis center in the monitored areas. It can be used to switch off dialysis water supply systems, dialysis concentrate preparation systems, dialysis concentrate supply systems, booster pump assemblies, and pre-filtration devices that are connected to the central control unit. This device can be used with the AquaA and AquaBplus water purification systems.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14437 | Reverse-osmosis water purification system | An assembly of devices designed to remove unwanted contaminants (bacteria, viruses, chemicals, dissolved substances) from water using osmotic pressure applied to one side of a selective membrane. The system removes ions, large molecules (e.g. proteins, glucose, urea, salts) and other particles from solution by forcing water at high pressure through a membrane containing pores just big enough (e.g., 0.0005 microns) to permit passage of small molecules and water, whilst the contaminants are flushed to waste. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04251285200517 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213507 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 115 KiloPascal