The labels
What the packs carry
The marks on this page are the ones printed on the three Medi Sense dialysis labels. Chengdu OCI Medical Devices Co., Ltd. is the manufacturer. Superior Healthcare International is the importer in Faisalabad. A certificate that is not on those labels is not claimed here.
On the labels
The kit, written in full
CE 1639
CE 1639 is printed on the dialyzer label, the fistula needle labels, and the blood tubing label. The same labels name an EU representative: Lepu Medical (Europe) Cooperatief U.A., Abe Lenstra Boulevard 36, 8448 JB, Heerenveen, the Netherlands. The manufacturer address is No. 2401 West Port Avenue, Southwest Airport Economic Development Zone, Shuangliu District, Chengdu, Sichuan, China.
The dialyzer
Model OCI-HD180L is a low flux polyethersulfone hollow fiber hemodialyzer, membrane area 1.8 m². It is for use only with a dialysis machine that controls ultrafiltration. The maximum transmembrane pressure is 500 mmHg (66.5 kPa). It is sterilised with ethylene oxide. It is single use, and it is not to be resterilised. Storage is dry, ventilated, and clean, in non-corrosive air, at 0–40°C, with relative humidity up to 80%.
The fistula needle sets
The sets are sterile arteriovenous fistula needle sets with a rotated wing, for hemodialysis blood access. The labelled sizes are OCI-16G in 25 mm and 32 mm, and OCI-17G in 25 mm and 32 mm. They are single use. Storage is dry and ventilated, at 0–40°C.
The blood tubing set
Model OCI-BL-HDA(a1-b1-c1-d1) is a sterile hemodialysis blood tubing set. It is pyrogen-free, sterilised with ethylene oxide, and single use. The stated shelf life is three years. Storage is dry, at 0–40°C, and the pack is not to be squeezed. The pump segment inside diameter is 9.8 mm. Some parts that contact blood are PVC containing DEHP.
What stays with the office
Registration numbers are held at the Faisalabad office. They are not printed on this page. A lot number or an expiry date on sample artwork belongs to that printed sample. It is not the only lot the office can quote. A buyer who needs a copy of a label, or a registration paper, writes to info@superiorhealthcareinternational.com or calls 041-2439027.
The other Medi Sense supplies are quoted from the same office. Each of those packs carries its own label. This page is the dialysis kit.
Ask the office
A copy, or a quotation
CE 1639
Printed on the dialyzer, the fistula needles, and the blood tubing.
Ethylene oxide
The dialyzer and the blood tubing. The dialyzer is not to be resterilised.
Single use
Dialyzer, fistula needles, and blood tubing. Each pack is finished after that use.
0°C to 40°C
Dry storage. The dialyzer label also limits relative humidity to 80%.