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Apheresis system tubing set - India CDSCO Medical Device Registration

Apheresis system tubing set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000596_162a17572c8ebc4d3258c58f73cd06ee_e148d1c5d4d15f0cc979a2dc9c00aaf6. This device is marketed under the brand name PLT & PLS SET W/FILTER, CONC PLT & PLS SET W/FILTER. The license holder is SPAN HEALTHCARE PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Apheresis system tubing set
UID: IMP/MD/2020/000596_162a17572c8ebc4d3258c58f73cd06ee_e148d1c5d4d15f0cc979a2dc9c00aaf6

Brand Name

PLT & PLS SET W/FILTER, CONC PLT & PLS SET W/FILTER

Device Class

Class C

Approving Authority

CDSCO

Product Information

The disposable set were introduced along with the UPP (PLT & PLS SET W/FILTER, CONC PLT & PLS SET W/FILTER). UPP is an enhanced version of the C-SDP protocol and offers a few advantages over C-SDP including an extracorporeal volume (PLT & PLS SET W/FILTER, CONC PLT & PLS SET W/FILTER) management, a new super surge draw mode and a platelet post-count estimate which allows the estimation of the concentration of platelets in the donor’s blood after completion of the collection procedure. In addition, the protocol allows the initiation of the plasma return sequence in parallel with the platelet collection sequence (PLT & PLS SET W/FILTER, CONC PLT & PLS SET W/FILTER) in order to spread the return of plasma over a longer time period. UPP will replace the other platelet collection devices over time.

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