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Arrow AC3 Optimus™ IABP System - HSA Registration DE0501398

Access comprehensive regulatory information for Arrow AC3 Optimus™ IABP 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 DE0501398 and owned by Arrow International LLC. The device was registered on March 16, 2018.

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
DE0501398
Arrow AC3 Optimus™ IABP System
HSA Registration Number: DE0501398
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Product Description

The Arrow AC3 Optimus™ IABP System is intended to provide counter-pulsation therapy when prescribed by an authorized physician.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0501398
Registration Date
March 16, 2018
Change Notification Approval Date
March 06, 2023
Retention Due Date
March 15, 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
83 CLEMENCEAU AVENUE, UE SQUARE, #05-05-08, SINGAPORE 239920
Model Information
Model Name(s)
AC3 Umbilical Cable AC3 UK Plug power Cord AC3 Australian Power Cord Slave Cable - Phone to Phone Cable IV Pole Mount Bracket for Display Head IV Pole Mount Bracket for Display Head Dual Hanger IV Pole Short Dual Hanger IV Pole Edwards Xducer Adapter Cable (Truwave) Gould Xducer Adapter Cable Cobe Xducer Adapter Cable 5 Lead ECG Cable Assembly AHA 5 Lead ECG Cable Assembly IEC 5 Lead ECG Main Trunk Cable 5 Lead ECG Main Trunk Cable 5 Lead Clip Ends AHA 5 Lead Clip Ends IEC Slave Cable - Siemens 1280 monitor connection to IABP AC3 Series PAK Slave Cable - Phone to 4.4mm Bantam Slave Cable - Phone to 3.5mm Miniphone Equipotential Ground Cable Recorder Paper AC3 N. American Power Cord AC3 Cont. Europe Power Cord Marquette Lemo Slave Cable assembly FIBEROPTIX® IAB Ultra® 8 IAB FIBEROPTIX® IAB Ultra® 8 IAB UltraFlex™ IAB UltraFlex™ IAB RediGuard® IAB RediGuard® IAB RediGuard® IAB Disposable Helium Tank 500psi Disposable Helium Tank 2000psi Refillable Helium tanks 2500 psi Refillable Helium Tank 2000 psi Disposable Helium Tank Adaptor DATASCOPE® 30cc & 40cc DATASCOPE®* 50cc Insertion Tray Insertion Tray Insertion Tray AC3 Optimus IABP ACAT/AutoCAT Series IABP Optional Battery Installation Instructions
Model Identifier(s)
IAA- 03714 IAA- 14690 IAA- 14695 IAA-00003 IAA-00170 IAA-00171 IAA-00175 IAA-00176 IAA-00401 IAA-00402 IAA-00405 IAA-00437 IAA-00437E IAA-00438 IAA-00438E IAA-00439 IAA-00439E IAA-00501 IAA-01004 IAA-03712 IAA-03720 IAA-03722 IAA-09004  IAA-14660 IAA-14680 IAA-H-8051 IAB-05830-LWS IAB-05830-U IAB-05840-LWS IAB-05840-U IAB-06830-U IAB-06840-U IAB-R950U IAB-S730C IAB-S840C IAH-09045 IAH-09046 IAH-09047 IAH-09048 IAH-09145 IAK-02263 IAK-02271 IAK-06845 IAK-S7IT IAK-S8IT IAP-0701 IAU-00100