Aquaboss® LA1107363
GUDID 04046964859854
EcoRO Dia II 3600
B.Braun Avitum AG
Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system Reverse-osmosis water purification system| Primary Device ID | 04046964859854 |
| NIH Device Record Key | bc362d16-54b6-4810-a6ff-ed793916652b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aquaboss® |
| Version Model Number | LA1107363 |
| Catalog Number | LA1107363 |
| Company DUNS | 343689704 |
| Company Name | B.Braun Avitum AG |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 and 75 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04046964859854 [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 | 2021-02-15 |
| Device Publish Date | 2016-09-23 |
On-Brand Devices [Aquaboss®]
| 04046964859854 | EcoRO Dia II 3600 |
| 04046964859830 | EcoRO Dia II 2800 |
| 04046964859816 | EcoRO Dia II 2450 |
| 04046964859793 | EcoRO Dia II 2100 |
| 04046964859779 | EcoRO Dia II 1800 |
| 04046964859755 | EcoRO Dia II 1400 |
| 04046964859731 | EcoRO Dia II 1050 |
| 04046964859724 | EcoRO Dia II 900 |
| 04046964859663 | EcoRO Dia I 2800 |
| 04046964859656 | EcoRO Dia I 2800 HT NA |
| 04046964859649 | EcoRO Dia I 2450 |
| 04046964859632 | EcoRO Dia I 2450 HT NA |
| 04046964859625 | EcoRO Dia I 2100 |
| 04046964859588 | EcoRO Dia I 1400 |
| 04046964859564 | EcoRO Dia I 1250 NA |
| 04046964859557 | EcoRO Dia I 1250 HT NA |
| 04046964859540 | EcoRO Dia I 1050 NA |
| 04046964859502 | EcoRO Dia I 700 HT NA |
Trademark Results [Aquaboss]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUABOSS 74074956 1682806 Live/Registered |
B. BRAUN AVITUM AG. 1990-07-02 |
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