Aquaboss® LA1107213
GUDID 04046964859786
EcoRO Dia II 2100 HT
LAUER Membran Wassertechnik GmbH
Reverse-osmosis water purification system| Primary Device ID | 04046964859786 |
| NIH Device Record Key | 6cffa60e-dd93-4018-87df-422e88ca4a06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aquaboss® |
| Version Model Number | LA1107213 |
| Catalog Number | LA1107213 |
| Company DUNS | 328246251 |
| Company Name | LAUER Membran Wassertechnik 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 | false |
| 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 |
Customer Support Contacts
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com | |
| Phone | +1(800)848-2066 |
| rtd.us@bbraun.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964859786 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K124059
FDA Product Code
| FIP | SUBSYSTEM, WATER PURIFICATION |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Aquaboss®]
| 04046964859892 | HOT RINSE SMART 50 |
| 04046964859885 | HOT RINSE SMART 40 |
| 04046964859878 | HOT RINSE SMART 30 |
| 04046964859861 | HOT RINSE SMART 10 HYDRAULIC UNIT |
| 04046964859847 | EcoRO Dia II 3600 HT |
| 04046964859823 | EcoRO Dia II 2800 HT |
| 04046964859809 | EcoRO Dia II 2450 HT |
| 04046964859786 | EcoRO Dia II 2100 HT |
| 04046964859762 | EcoRO Dia II 1800 HT |
| 04046964859748 | EcoRO Dia II 1250 |
| 04046964859717 | EcoRO Dia II 900 HT |
| 04046964859700 | EcoRO Dia II 700 |
| 04046964859694 | EcoRO Dia II 700 HT |
| 04046964859687 | EcoRO Dia I 3600 |
| 04046964859670 | EcoRO Dia I 3600 HT NA |
| 04046964859618 | ECORO DIA I 2100 HT NA |
| 04046964859601 | EcoRO Dia I 1800 |
| 04046964859595 | EcoRO Dia I 1800 HT NA |
| 04046964859571 | EcoRO Dia I 1400 HT NA |
| 04046964859533 | EcoRO Dia I 1050 HT NA |
| 04046964859526 | EcoRO Dia I 900 HT NA |
| 04046964859519 | EcoRO Dia I 700 |
| 04046964843037 | HOT RINSE SMART 20 |
| 04046964842931 | EcoRO Dia II 1400 HT |
| 04046964841866 | EcoRO Dia II 1050 HT |
Trademark Results [Aquaboss]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUABOSS 74074956 1682806 Live/Registered |
B. BRAUN AVITUM AG. 1990-07-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.