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Smiths Medical Deltec Power P.A.C. Venous Access Systems - HSA Registration DE0013053

Access comprehensive regulatory information for Smiths Medical Deltec Power P.A.C. Venous Access Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0013053 and owned by Smiths Medical ASD, Inc.. The device was registered on May 30, 2013.

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
DE0013053
Smiths Medical Deltec Power P.A.C. Venous Access Systems
HSA Registration Number: DE0013053
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Product Description

The POWER P.A.C. Implantable Venous Access Systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. Safety Huber Needle or other power injectable huber needle, the POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec.

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0013053
Registration Date
May 30, 2013
Change Notification Approval Date
August 08, 2023
Retention Due Date
May 29, 2025
Product Owner
Short Name
Smiths Medical ASD, Inc.
Address
6000 Nathan Lane North, Minneapolis MN 55442, UNITED STATES
Registrant
Address
1 KALLANG JUNCTION, Vanguard Campus, #05-01, SINGAPORE 339263
Importer
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model Information
Model Name(s)
PORT-A-CATH® POWER P.A.C. Titanium Venous Access System PORT-A-CATH® POWER P.A.C. Titanium Venous Access System PORT-A-CATH® POWER P.A.C. Titanium Venous Access System PORT-A-CATH® POWER P.A.C. Titanium Venous Access System PORT-A-CATH® POWER P.A.C. Low Profile™ Titanium Venous Access System PORT-A-CATH® POWER P.A.C. Low Profile™ Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Pre-assembled Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Pre-assembled Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Low Profile™ Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Low Profile™ Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Low Profile™ Pre-assembled Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Low Profile™ Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Low Profile™ Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Low Profile™ Pre-assembled Polysulfone/Titanium Venous Access System P.A.S. PORT® T2 POWER P.A.C. Titanium Venous Access System P.A.S. PORT® T2 POWER P.A.C. Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Dual-Lumen Low Profile™ Polysulfone/Titanium Venous Access System PORT-A-CATH® II POWER P.A.C. Dual-Lumen Low Profile™ Polysulfone/Titanium Venous Access System
Model Identifier(s)
21-4422-24 21-4423-24 21-4424-24 21-4425-24 21-4436-24 21-4437-24 21-4452-24 21-4453-24 21-4454-24 21-4455-24 21-4463-24 21-4465-24 21-4470-24 21-4471-24 21-4473-24 21-4482-24 21-4483-24 21-4485-24 21-4872-24 21-4873-24 21-8466-24 21-8468-24