Nuwellis Inc.

Address:12988 Valley View Rd,Eden Prairie,MN,55344,US

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- Catalog Number : 114157

Device Description : The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr 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.

Device Class :

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 114156

Device Description : The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr 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.

Device Class : 2

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr 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.

Device Class : 2

Duns Number: 790580182

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

- Catalog Number : 114158

Device Description : The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr 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.

Device Class : 2

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration tr 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.

Device Class : 2

Duns Number: 790580182

Premarket Exempt : No

Product Code : MPB

Prescription Use : Yes

Device Count : 1

Device Description : The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therap The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

Device Class : 2

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : For use with the Aquadex System. The Aquadex System is indicated for: Continuous For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

Device Class :

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 114157

Device Description : For use with the Aquadex System. The Aquadex System is indicated for: Continuous For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

Device Class :

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : For use with the Aquadex System. The Aquadex System is indicated for: Continuous For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.

Device Class : 2

Duns Number: 790580182

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1