Aquadex SmartFlow Console

Primary DI
10853072007104
Brand
Aquadex SmartFlow Console
Company
Nuwellis Inc.
Model
120100
Catalog number
120100
Device description
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.
Published
2020-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192756000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192756000Aquadex FlexFlow System 2.0Chf Solutions, Inc.2020-02-24KDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853072007104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085307200710410853072007104

GMDN Terms#

Term, Definition table
TermDefinition
Haemofiltration systemAn assembly of mains electricity (AC-powered) devices used to perform haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a filter to allow for the removal of toxins and fluids, and/or the replacement of electrolytes. It typically consists of an extracorporeal blood pump circuit, tubing, catheters, solution mixer, and an operator's console with a monitor. The system functions with dialysate solution and a haemofilter for the transfer of substances by diffusion and convection (ultrafiltration).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-30 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-786-2778support@chf-solutions.com
1-855-786-2778support@nuwellis.com

Regulatory Flags#

DUNS number
790580182
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10853072007173Dual Lumen Extended Length Catheter (15cm)3201023201022024-02-20
10853072007210Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit3201113201112024-02-20
10853072007289AquaFlexFlow UF 500 Plus - 24 Hr2101042101042021-11-23
10853072007159Dual Lumen Extended Length Catheter (11cm)3201013201012024-02-20
10853072007111AquaFlexFlow UF 500 Plus1141561141562020-03-03
10853072007128AquaFlexFlow UF 5001141571141572020-03-03
10853072007234Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit3201123201122024-02-20
30853072007184Dual Lumen Extended Length Catheter (15cm)3201023201022024-02-20
30853072007221Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit3201113201112024-02-20
30853072007245Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit3201123201122024-02-20
30853072007306AquaFlexFlow UF 500 Plus - 24 Hr2101042101042021-11-23
10853072007029Blood Circuit SetUF 500-HCT1141562018-02-22
10853072007043Dual Lumen Extended Length Catheter1141531141532018-08-16
10853072007081Dual Lumen Extended Length Catheter and GALT insertion kit1154631154632018-05-24
30853072007030Blood Circuit SetUF 500-HCT1141562018-02-22
10853072007074Aquadex FlexFlow1141581141582018-01-11
10853072007005Blood Circuit SetUF 5001141572018-02-22

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