Aquadex FlexFlow 114158
GUDID 07332414112301
The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic thera
GAMBRO UF SOLUTIONS, INC
Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system Haemofiltration system| Primary Device ID | 07332414112301 |
| NIH Device Record Key | f5228c4b-85a2-46bc-abfc-4cc9fd7c2797 |
| Commercial Distribution Discontinuation | 2017-07-14 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Aquadex FlexFlow |
| Version Model Number | 114158 |
| Catalog Number | 114158 |
| Company DUNS | 132629788 |
| Company Name | GAMBRO UF SOLUTIONS, INC |
| 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
Operating and Storage Conditions
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332414112301 [Primary] |
FDA Product Code
| KDI | Dialyzer, high permeability with or without sealed dialysate system |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2015-10-07 |
Devices Manufactured by GAMBRO UF SOLUTIONS, INC
| 57332414112269 - NA | 2018-10-29 A6001 5L Effluent Bag |
| 07332414112301 - Aquadex FlexFlow | 2018-03-29The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic thera |
| 07332414112301 - Aquadex FlexFlow | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 27332414112367 - Dual Lumen Extended Length Catheter | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 37332414112371 - Blood Circuit Set | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 37332414112388 - Blood Circuit Set | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 37332414119325 - Dual Lumen Extended Length Catheter and GALT inser | 2018-03-29 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
Trademark Results [Aquadex FlexFlow]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AQUADEX FLEXFLOW 85771347 4837116 Live/Registered |
CHF SOLUTIONS, INC. 2012-11-05 |
 AQUADEX FLEXFLOW 78573157 not registered Dead/Abandoned |
CHF Solutions, Inc. 2005-02-23 |
 AQUADEX FLEXFLOW 77907801 not registered Dead/Abandoned |
GAMBRO LUNDIA AB 2010-01-08 |
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