Heart Lung pack - India CDSCO Medical Device Registration

Heart Lung pack is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000005_1617c47448221fac6625cb3687a4accd_2f1aff0bfef068d9bd36449dfc3f0398. This device is marketed under the brand name PrymaX Dialysis. The license holder is Prymax Healthcare LLP,, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

Heart Lung pack

UID: MFG/MD/2021/000005_1617c47448221fac6625cb3687a4accd_2f1aff0bfef068d9bd36449dfc3f0398

Brand Name

PrymaX Dialysis

License Holder

Prymax Healthcare LLP,

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

This is combination of PVC Tubing, Arterial Filter and connector as extracorporeal circuit to carry blood from the patient to the Heart Lung Machine/Oxygenator. This set is intended for use during surgery requiring cardiopulmonary or surgical technique.The device is single use, non-toxic, pyrogen-free & supplied sterile. The device is sterilized by ethylene oxide. The level of ethylene oxide residuals in the device is within the limits established by national regulations in the country of use