Aquadex FlexFlow 114158
GUDID 10853072007074
The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
Nuwellis 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 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 | 10853072007074 |
| NIH Device Record Key | 5ec3909a-094c-4041-bc30-cc046e5e6b0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aquadex FlexFlow |
| Version Model Number | 114158 |
| Catalog Number | 114158 |
| Company DUNS | 790580182 |
| Company Name | Nuwellis 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
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -22 Degrees Fahrenheit and 122 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10853072007074 [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 | 3 |
| Public Version Date | 2021-11-25 |
| Device Publish Date | 2018-01-11 |
Devices Manufactured by Nuwellis Inc.
| 10853072007159 - Dual Lumen Extended Length Catheter (11cm) | 2024-02-28 The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically f |
| 30853072007184 - Dual Lumen Extended Length Catheter (15cm) | 2024-02-28 The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically f |
| 30853072007221 - Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit | 2024-02-28 This Kit includes a dELC Catheter (11cm) and a GALT Insertion Kit. The dELC is a 6 F reverse taper dual lumen venous access dev |
| 30853072007245 - Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit | 2024-02-28 This Kit includes a dELC Catheter (15cm) and a GALT Insertion Kit. The dELC is a 6 F reverse taper dual lumen venous access dev |
| 30853072007306 - AquaFlexFlow UF 500 Plus - 24 Hr | 2021-12-01 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 |
| 30853072007030 - Blood Circuit Set | 2021-11-25 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 10853072007074 - Aquadex FlexFlow | 2021-11-25The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization. |
| 10853072007074 - Aquadex FlexFlow | 2021-11-25 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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