| Primary Device ID | 30853072007092 |
| NIH Device Record Key | 4a061d55-2fe2-4018-8153-2b80cca589b6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dual Lumen Extended Length Catheter and GALT insertion kit |
| Version Model Number | 115463 |
| Catalog Number | 115463 |
| Company DUNS | 790580182 |
| Company Name | CHF 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.com | |
| Phone | 1-855-786-2778 |
| support@chf-solutions.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 | |
| Phone | 1-855-786-2778 |
| support@nuwellis.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10853072007081 [Primary] |
| GS1 | 30853072007092 [Package] Contains: 10853072007081 Package: Box [5 Units] In Commercial Distribution |
| MPB | Catheter, Hemodialysis, Non-Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-02-05 |
| Device Publish Date | 2018-05-24 |
| 10853072007005 - Blood Circuit Set | 2021-11-23 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 50853072007065 - Dual Lumen Extended Length Catheter | 2021-02-05 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 30853072007092 - Dual Lumen Extended Length Catheter and GALT insertion kit | 2021-02-05The 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. |
| 30853072007092 - Dual Lumen Extended Length Catheter and GALT insertion kit | 2021-02-05 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have |
| 10853072007104 - Aquadex SmartFlow Console | 2020-03-11 The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (lon |
| 10853072007111 - AquaFlexFlow UF 500 Plus | 2020-03-11 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 |
| 10853072007128 - AquaFlexFlow UF 500 | 2020-03-11 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 |