← Back to catalogue

Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K100334

by B.Braun Avitum AG

Identifiers

510(k) Number
K100334 FDA 510(k)
FDA Product Code
KDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5860 FDA 510(k)
Regulation Number
876.5860 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Diacap Polysulfone HiFlo 23 Hemodialyzer is a high-permeability dialyzer designed for hemodialysis. It features polysulfone hollow fiber capillary membranes housed in a polycarbonate casing with polyurethane potting resin and silicone O-rings, enabling efficient blood purification for both acute and chronic dialysis treatments.

This single-use device is intended for use in dialysis settings and requires sterile handling. Supplied as a sterile, disposable unit, it adheres to FDA 510(k) and MDR regulatory standards. The model 72036811 is classified under FDA regulation 876.5860 as a Class II device, with a clearance type designated as Special.

Frequently asked questions

Is this hemodialyzer reusable or designed for single-use only, and why does that matter for my facility?

The Diacap Polysulfone HiFlo 23 Hemodialyzer (model 72036811) is explicitly designed for single-use only. This is critical because single-use devices eliminate the need for sterilization between patients, reducing the risk of cross-contamination and infection. The manufacturer emphasizes sterile handling, which aligns with best practices for hemodialysis to ensure patient safety and compliance with regulatory standards like FDA 510(k) and MDR.

What materials are used in the construction of this hemodialyzer, and how might they impact its performance or compatibility with my dialysis system?

The device features polysulfone hollow fiber capillary membranes housed in a polycarbonate casing with polyurethane potting resin and silicone O-rings. These materials are chosen for their durability, biocompatibility, and high permeability, which are essential for efficient blood purification during hemodialysis. The combination ensures compatibility with standard dialysis systems while maintaining structural integrity and minimizing the risk of adverse reactions during treatment.

How should I store this hemodialyzer before use, and are there any specific conditions that must be met?

While the data does not specify exact storage conditions, the hemodialyzer is supplied as a sterile, disposable unit, meaning it must be stored in its original packaging to preserve sterility. It should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always check the packaging for expiration dates or storage instructions provided by the manufacturer to ensure optimal performance and compliance with regulatory requirements.

What regulatory pathways has this device undergone, and how does that affect its use in clinical settings?

The Diacap Polysulfone HiFlo 23 Hemodialyzer has undergone FDA 510(k) clearance and MDR (Medical Device Regulation) authorization, confirming its compliance with stringent safety and performance standards. This classification as a Class II device under FDA regulation 876.5860 indicates it has undergone a special review process, ensuring it meets established benchmarks for hemodialysis devices. Clinically, this means it can be confidently used for both acute and chronic dialysis treatments in regulated settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811, Diacap Polysulfone Hiflo 23 Hemodilayzer , Model 72036811, DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 510 (k ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
B.Braun Avitum AG
FDA Applicant
B. Braun Avitum AG

Sources (2)

  • FDA 510(k) K100334 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 29, 2026