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Hemodialysis Catheter Kit/Set - India CDSCO Medical Device Registration

Hemodialysis Catheter Kit/Set is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000445_fead056457f2c323268a4ce87746b53e_018cd3ae4fb4136fa66ae0e55d53db63. This device is marketed under the brand name ABLECATH. The license holder is ASPIROM HEALTHCARE, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Hemodialysis Catheter Kit/Set
UID: IMP/MD/2019/000445_fead056457f2c323268a4ce87746b53e_018cd3ae4fb4136fa66ae0e55d53db63

Brand Name

ABLECATH

License Holder

ASPIROM HEALTHCARE

Device Class

Class C

Approving Authority

CDSCO

Product Information

The ABLE Central Venous Catheters Kit/Set may be applicable to one of the following therapy: -Monitor of Central Venous Pressure -Continuous or Discontinuous Venous Transfusion -Blood sampling The catheter is surgically penetrated into three optional puncture points depended on the clinical requirement with Seldinger Technique. The insertion sites are: 1. Internal Jugular Vein 2. Subclavian Vein 3. Femoral vein It is possible to be inserted inside the body for less than days. If duration exceeds 30 days, it may occur the risk of combining the catheter and inside tissue, which result in serious incident.

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