FDA.reportPublic FDA data

Moda-flx Hemodialysis System

Primary DI
00860008016959
Brand
Moda-flx Hemodialysis System
Company
Diality Inc
Model
102507-001
Catalog number
N/A
Device description
Moda-flx Disposable Acid Straws
Published
2025-07-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FIPSubsystem, Water Purification
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIPSubsystem, Water PurificationGastroenterology, Urology2
FJKSet, Tubing, Blood, With And Without Anti-Regurgitation ValveGastroenterology, Urology2
KDIDialyzer, High Permeability With Or Without Sealed Dialysate SystemGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860008016959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860008016959008600080169598600080169590860008016959

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis system, institutional/home-useAn assembly of mains electricity (AC-powered) devices designed to perform haemodialysis, a treatment whereby extracorporeal blood is passed through a filter to allow for the removal of toxins and/or the replacement of electrolytes. The system functions with dialysate solution and a haemodialysis dialyser (haemodialyzer) for the transfer of substances by diffusion, osmosis and ultrafiltration. The system typically includes a pump and tubing to circulate blood through the haemodialysis dialyser, a solution mixer to prepare the dialysate, a monitor with system controls, and other dedicated components.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-619-0079support@diality.com

Regulatory Flags#

DUNS number
105303391
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008016942Moda-flx Hemodialysis System102508-001N/A2025-07-16
00860008016973Moda-flx Hemodialysis System102550-001N/A2025-07-16
00860008016904Moda-flx Hemodialysis System101304-001N/A2025-07-16
00860008016911Moda-flx Hemodialysis System102072-001N/A2025-07-16
00860008016928Moda-flx Hemodialysis System101747-001N/A2025-07-16
00860008016935Moda-flx Hemodialysis System102508-001N/A2025-07-16
00860008016966Moda-flx Hemodialysis System102492-001N/A2025-07-16
10860008016970Moda-flx Hemodialysis System102550-001N/A2025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07332414202309TherMaxVantive Health GmbHKDI2026-07-06
08056992333536HEMOCOR HPH MINI - PEDIATRICMEDICA SPAKDI2026-07-06
06948082774904NovaLineBain Medical Equipment (Guangzhou) Co., Ltd.FJK2026-06-04
07332414200183RevaclearVantive Health GmbHKDI2026-05-29
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
00383790011877SLIMLINE™ BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00383790011884NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00383790011891NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
00383790011907NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SETNIPRO MEDICAL CORPORATIONFJK2025-06-01
RO0258E-2436RO, 8640GPD, 208V, 4MEMBETTER WATER, LLCFIP2024-11-13
00085412908397RevaclearBaxter Healthcare SAKDI2024-04-12
00085412908427RevaclearBaxter Healthcare SAKDI2024-04-12
00085412908434RevaclearBaxter Healthcare SAKDI2024-04-12
M535NX100010G0VersiHD with GuideMe softwareNXSTAGE MEDICAL, INC.KDI2024-01-25
M535FWS3090EXPRESS FLUID WARMER DISPOSABLENXSTAGE MEDICAL, INC.KDI2023-11-20
08051736007049CLEARUM HSMozarc Medical US LLCKDI2023-08-04
05060497260153Bicarbonate Spare Connectors SetQUANTA DIALYSIS TECHNOLOGIES LIMITEDKDI2023-07-13
05060497260160Quanta Dialysis SystemQUANTA DIALYSIS TECHNOLOGIES LIMITEDKDI2023-07-03
00085412917696PRISMAFLEX SETGAMBRO INDUSTRIESKDI2022-11-22
00085412954073PRISMAFLEX SETGAMBRO INDUSTRIESKDI2022-11-22
00085412954103PRISMAFLEX SETGAMBRO INDUSTRIESKDI2022-11-22
M535NX100010B0VersiHDNXSTAGE MEDICAL, INC.KDI2021-12-08