Aquadex FlexFlow

Primary DI
10853072007074
Brand
Aquadex FlexFlow
Company
Nuwellis Inc.
Model
114158
Catalog number
114158
Device description
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.
Published
2018-01-11
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853072007074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085307200707410853072007074

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-22 Degrees Fahrenheit122 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
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
10853072007104Aquadex SmartFlow Console1201001201002020-03-03
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
10853072007005Blood Circuit SetUF 5001141572018-02-22

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