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Arrow Pressure Injectable Central Venous Catheterization Kit, ARROWg+ard Blue PLUS® - HSA Registration DE0016849

Access comprehensive regulatory information for Arrow Pressure Injectable Central Venous Catheterization Kit, ARROWg+ard Blue PLUS® in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0016849 and owned by Arrow International LLC. The device was registered on February 23, 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
DE0016849
Arrow Pressure Injectable Central Venous Catheterization Kit, ARROWg+ard Blue PLUS®
HSA Registration Number: DE0016849
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Product Description

Arrow Pressure Injectable Central Venous Catheterization Kit, ARROWg+ard Blue PLUS® permits venous access to the central circulation by way of the femoral, jugular, or subclavian veins. 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 (> 30 days).

Device Classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDD00110
HS Code
90183910
Registration Information
Registration Number
DE0016849
Registration Date
February 23, 2015
Change Notification Approval Date
May 09, 2024
Retention Due Date
February 22, 2026
Product Owner
Short Name
Arrow International LLC
Address
3015 Carrington Mill Blvd., Morrisville, North Carolina 27560, UNITED STATES
Registrant
Address
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Importer
Address
1 KALLANG JUNCTION, #05-01, SINGAPORE 339263 83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Model Information
Model Name(s)
Pressure Injectable Multi-Lumen Central Venous Catheterization Kit, ARROWg+ard Blue PLUS® Pressure Injectable Quad-Lumen Central Venous Catheterization Kit, ARROWg+ard Blue PLUS® Pressure Injectable Multi-Lumen Central Venous Catheterization Kit, ARROWg+ard Blue PLUS® Pressure Injectable Quad-Lumen Central Venous Catheterization Kit, ARROWg+ard Blue PLUS®
Model Identifier(s)
CS-42703-HP CS-42854-HP CS-45703-HP CS-45854-HP