FDA.reportPublic FDA data

Blood Circuit Set

Primary DI
10853072007029
Brand
Blood Circuit Set
Company
Nuwellis Inc.
Model
UF 500-HCT
Catalog number
114156
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
2018-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
30853072007030PackageGS15In Commercial Distribution
10853072007029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085307200703030853072007030
1085307200702910853072007029

GMDN Terms#

Term, Definition table
TermDefinition
HaemofilterA filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
790580182
Device count
1
Lot or batch
true
Expiration date on label
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
00842289103764EXPRESS FLUID WARMERNXSTAGE MEDICAL, INC.KDI2026-04-29
00842289103719VersiHDNXSTAGE MEDICAL, INC.KDI2026-04-22
08056992333543HPH-700 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333550HPH-700TS HEMOCONCENTRATMEDICA SPAKDI2026-04-01
08056992333567HPH-400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333574HPH-1000 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333581HPH-1400 HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333598HPH-400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333604HPH-1000TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333611HPH-1400TS HEMOCONCENTRATORMEDICA SPAKDI2026-04-01
08056992333628HPH JUNIORMEDICA SPAKDI2026-04-01
07332414201340PRISMAFLEX SET M100Vantive Health GmbHKDI2026-03-27
04039361259150FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259570FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259594FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259617FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259631FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259655FX CorALFresenius Medical Care AGKDI2026-01-02
04039361259938FX CorALFresenius Medical Care AGKDI2026-01-02
00383790012379Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012386Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012393Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012409Blood pressure cuff for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
00383790012416Blood pressure cuff hose for SURDIAL DX Hemodialysis SystemNIPRO MEDICAL CORPORATIONKDI2025-12-19
04987671041708Hemodialysis Delivery SystemNIKKISO CO.,LTD.KDI2025-08-22
00860008016942Moda-flx Hemodialysis SystemDiality IncKDI2025-07-16
00860008016973Moda-flx Hemodialysis SystemDiality IncKDI2025-07-16
00383790011914Nipro Set Blood Tubing SetNIPRO MEDICAL CORPORATIONKDI2025-06-01
04987671030214Filter for dialysate purificationNIKKISO CO.,LTD.KDI2025-04-07