CDSCO UID IMP/MD/2021/000259_a540451858ea5adde3fcaad30222015e_62d8af4004fc8e8b9c918439dba87877

Central Venous Catheter 10

Teleflex Medical Private Limited·Device Class Class C·India CDSCO·Brand: Arrow®
Registration details
UID
IMP/MD/2021/000259_a540451858ea5adde3fcaad30222015e_62d8af4004fc8e8b9c918439dba87877
Device class
Class C
Brand name
Arrow®
Approving authority
CDSCO
Product information
Intended Use: The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (Arrow®). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (Arrow®). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue® catheter has not been studied. Indications for Use: The Arrowg+ard Blue Plus antimicrobial catheter is indicated to permit short-term (Arrow®) central venous access for the treatment of diseases or conditions requiring central venous access, including, but not limited to the following:• Lack of usable peripheral IV sites• Central venous pressure monitoring• Total parenteral nutrition (Arrow®)• Infusions of fluids, medications, or chemotherapy• Frequent blood sampling or receiving blood transfusions/blood products. The catheter is not intended to be used as a treatment for existing infections nor as a substitute for a tunneled catheter in those patients requiring long-term therapy. One clinical study indicates antimicrobial properties of the catheter may not be effective when it is used to administer TPN
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About this record

Central Venous Catheter 10 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000259_a540451858ea5adde3fcaad30222015e_62d8af4004fc8e8b9c918439dba87877. This device is marketed under the brand name Arrow®. The license holder is Teleflex Medical Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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