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We've been running these through the usual battery of tests—HPLC for residual monomers, pressure decay for fiber integrity—and the batch-to-batch consistency has been tight, roughly within 2% on clearance rates for urea and creatinine across the last ten. The 1.8-hour label refers to the expected treatment time at standard blood flow rates, not any product property per se, and the membrane inner diameter is 200μm with a 35μm wall thickness, which basically determines how well middle molecules like beta-2 microglobulin get pulled out.
Adult patients are the main group, but we have some centers using the 1.2m² surface area version for pediatric cases, and the gamma sterilization means it's ready to go straight out of the box—no extra prep needed. It's better than some lower-flux designs for removing larger toxins, though it's not suited for patients with severe heparin allergies or those on certain anticoagulant protocols where the higher flux might cause excessive fluid shifts.
The CE mark is current, and our company provide a COA with each batch showing endotoxin levels below 0.03 EU/mL and fiber bundle volume within spec—usually 85-95 mL depending on the surface area you order. One thing buyers don't always ask: we retain a sealed sample form every production lot for 18 months, so if there's ever a question, we can pull it for retesting.
Lead time is typically 20 days or so from order confirmation, but if you need a specific surface area like 1.4m² or 1.6m², we usually have stock, though confirm lead time for 1.8m² as it moves faster. Teh MOQ is 500 units for a standdard order, but our company can do smaller trial quantities at a slightly higher per-unit cost.
Also, the potting compound is polyurethane, and we've had no issues with biocompatibility in the last three years of production—it's one of those details that matters if you're running a tight validation protocol. The housing is transparent polycarbonate, so you can actually see the blood flow during treatment, which some clinicians find useful for spotting air bubbles.
We offer surface areas of 1.2m², 1.4m², 1.6m², and 1.8m². Your choice depends on the patient's body size and treatment needs; for example, the 1.8m² is typically used for larger adults, while the 1.2m² is suitable for children.
Our MOQ for the High Flux 1.8h Polysulfone Dialyzer is typically 500 units per order. However, we can discuss smaller trial orders if you're just starting out.
Yes, we include CE certification documents along with the GB/T 32610 safety standard compliance paperwork. You'll get a full quality package with each order.
Store them in a cool, dry place away from direct sunlight, ideally at room temperature (10-30°C). The gamma ray sterilization keeps them sterile until the packaging is opened, so just keep the boxes sealed.
Currently, the housing is fixed as polycarbonate and the potting compound as polyurethane, as these are standard for our production. Customization on these materials would require a large volume order and additional testing.
Keenly impressed with the delivery speed; my order arrived much sooner than anticipated, which was a pleasant surprise. The packaging was secure and intact, ensuring the product was well-protected during transit. Regarding quality, the materials feel durable and well-crafted, reflecting a high standard of manufacturing. Customer service was exceptional—they were responsive and helpful, addressing my queries promptly and professionally. Overall, a very satisfying experience that I would highly recommend to others.
