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Bardยฎ Power-Trialysis Short-Term Dialysis Catheter - HSA Registration DE0016687

Access comprehensive regulatory information for Bardยฎ Power-Trialysis Short-Term Dialysis Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0016687 and owned by Bard Access Systems, Inc.. The device was registered on December 24, 2014.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0016687
Bardยฎ Power-Trialysis Short-Term Dialysis Catheter
HSA Registration Number: DE0016687
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Product Description

The Bard Power-Trialysis Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0016687
Registration Date
December 24, 2014
Change Notification Approval Date
June 29, 2022
Retention Due Date
December 23, 2025
Product Owner
Short Name
Bard Access Systems, Inc.
Address
605 North 5600 West, Salt Lake City, Utah, 84116, UNITED STATES
Registrant
Address
10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Importer
Address
10 ANSON ROAD, INTERNATIONAL PLAZA, #33-07/08, SINGAPORE 079903 10 COLLYER QUAY, OCEAN FINANCIAL CENTRE, #10-01, SINGAPORE 049315
Model Information
Model Name(s)
Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter Bard Power-Trialysis Short-Term Dialysis Catheter
Model Identifier(s)
5608150 5608200 5608240 5608300 5618120 5618150 5618200 5618240