| Primary Device ID | 04251285200227 |
| NIH Device Record Key | ffdad594-eea4-4af2-accf-319a44c91a48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AquaBplus & AquaBplus B2 & AquaBplus HF |
| Version Model Number | 2500 |
| Company DUNS | 341685795 |
| Company Name | VIVONIC GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04251285200227 [Primary] |
| FIP | Subsystem, Water Purification |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 04251285200227 | The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia |
| 04251285200210 | The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia |
| 04251285200203 | The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia |
| 04251285200197 | The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia |
| 04251285200180 | The AquaBplus Water Purification Systems are reverse osmosis units intended for use with hemodia |