Central Venous Catheter 9 - India CDSCO Medical Device Registration

Central Venous Catheter 9 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000259_8d2ed56d4a2031be939a794eeb964b22_96a4a60c377ce4940ff369ebaa2fde8b. 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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CDSCO Registered

Class Class C

Central Venous Catheter 9

UID: IMP/MD/2021/000259_8d2ed56d4a2031be939a794eeb964b22_96a4a60c377ce4940ff369ebaa2fde8b

Brand Name

Arrow®

License Holder

Teleflex Medical Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

Intended Use: The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (Arrow®). Indications for Use: The Arrowg+ard Blue 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

Class B

Introducer Sheaths 12

Brand: Arrow®

Teleflex Medical Private Limited

Class C

Brand: MiniLap®

Class B