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510(k) Data Aggregation
K Number
K243607Device Name
Moda-flx Hemodialysis System Cartridge (102121-001 )
Manufacturer
Diality, Inc.
Date Cleared
2024-12-20
(29 days)
Product Code
FJK
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
Diality, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System ™
Device Description
The Moda-flx Hemodialysis System™ Cartridge is a single use blood tubing set that provides extracorporeal access during hemodialysis and is only compatible with Moda-flx Hemodialysis System™
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K Number
K233798Device Name
Moda-flx Hemodialysis System and Cartridge
Manufacturer
Diality, Inc.
Date Cleared
2024-08-02
(247 days)
Product Code
KDI, FIP, FJK
Regulation Number
876.5860Why did this record match?
Applicant Name (Manufacturer) :
Diality, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System TM.
Device Description
The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device. Dialysate Generator (DG) Device, and a single use Moda-flx Hemodialysis System™ Cartridge that provides extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is only compatible with the Modaflx Hemodialysis System™. The system creates purified water from tap water; from this purified water and chemical concentrates, the system creates dialysate in real time. The chemicals used to create the dialysate are standard 45X concentrates.
Ultrafiltration is achieved by controlling the dialysate going in and coming out of the dialyzer independently, using pumps on the HD Device to control fluid flow from both the inlet and outlet of the dialyzer. An external bag of saline is used to provide solution infusions to combat hypotensive episodes. Saline is also used to prime the Moda-flx Hemodialysis System™ Cartridge prior to use.
Prescribed blood flow rate is generated by a peristaltic pump, while heparin is administered to prevent blood coagulation. All fluid pathways are disposable and easily installed and replaced. Once installed, the device will check the connections of the fluid pathways and the system will automatically prepare itself for treatment.
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