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| 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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