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| 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 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.