AquaFlexFlow UF 500 Plus

Primary DI
10853072007111
Brand
AquaFlexFlow UF 500 Plus
Company
Nuwellis Inc.
Model
114156
Catalog number
114156
Device description
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.
Published
2020-03-03
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

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
30853072007139PackageGS15In Commercial Distribution
10853072007111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085307200713930853072007139
1085307200711110853072007111

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
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-786-2778support@chf-solutions.com
1-855-768-2778support@nuwellis.com

Regulatory Flags#

DUNS number
790580182
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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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