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Bard PowerPICC Catheter System - HSA Registration DE0016864

Access comprehensive regulatory information for Bard PowerPICC Catheter System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0016864 and owned by Bard Access Systems, Inc.. The device was registered on February 27, 2015.

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
DE0016864
Bard PowerPICC Catheter System
HSA Registration Number: DE0016864
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Product Description

The PowerPICC and SOLO2 catheters are indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy, use a 4 Fr or larger catheter. The maximum recommended infusion rate is 5 ml/s for power injection of contrast media. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General & Plastic Surgery
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0016864
Registration Date
February 27, 2015
Change Notification Approval Date
July 25, 2024
Retention Due Date
February 26, 2026
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)
PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2โ„ข Catheter, Basic Tray with MicroEZ* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICCยฎ Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICCยฎ Catheter with 135 cm Nitinol Guidewire and MicroEZโ„ข Microintroducer in Radiology Basic Kit PowerPICCยฎ Catheter with 70 cm Nitinol Guidewire and MicroEZโ„ข Microintroducer in Radiology Basic Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2โ„ข Catheter with 135 cm Nitinol Guidewire and MicroEZโ„ข Microintroducer in Radiology Basic Kit PowerPICC SOLO2โ„ข Catheter with 70 cm Nitinol Guidewire and MicroEZโ„ข Microintroducer in Radiology Basic Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter, Basic Tray with MicroEZ* Microintroducer Kit PowerPICC SOLO2* Catheter with 135 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit PowerPICC SOLO2* Catheter with 70 cm Nitinol Guidewire and RadSTIC* Microintroducer in Basic Kit
Model Identifier(s)
4174118 4175118 4194118 4195118 4275118 4295118 4375118 4386118 4395118 4396118 8174118 8174335 8174355 8175118 8175335 8175355 8194118 8194335 8194355 8195118 8195335 8195355 8275118 8275335 8275355 8276118 8276335 8276355 8295118 8295335 8295355 8375118 8375335 8375355 8386118 8386335 8386355 8395118 8395335 8395355 8396118 8396335 8396355