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Datascope Cardiosave™ Intra-Aortic Balloon Pump (IABP) - HSA Registration DE0013818

Access comprehensive regulatory information for Datascope Cardiosave™ Intra-Aortic Balloon Pump (IABP) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0013818 and owned by Datascope Corp. The device was registered on September 13, 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 C
DE0013818
Datascope Cardiosave™ Intra-Aortic Balloon Pump (IABP)
HSA Registration Number: DE0013818
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Product Description

is an electromechanical system used to inflate and deflate intra-aortic balloons. It provides temporary support to the left ventricle via the principle of counterpulsation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0013818
Registration Date
September 13, 2013
Change Notification Approval Date
April 14, 2025
Retention Due Date
September 12, 2025
Product Owner
Short Name
Datascope
Address
1300 McArthur Boulevard, Mahwah, New Jersey, 07430, UNITED STATES
Registrant
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914
Importer
Address
20 BENDEMEER ROAD, #06-01/02, SINGAPORE 339914 1 KALLANG JUNCTION, #05-01, SINGAPORE 339263
Model Information
Model Name(s)
Tool, 1/16" Hex Key External Signal Cable 20' Cable Interfaces BP & ECG for HP/ Philips Monitors, except CMS, Viridia or Intellivue 30' Cable Interfaces BP & ECG for HP/ Philips Monitors, except CMS, Viridia or Intellivue 20' Cable Interfaces ECG for HP/ Philips CMS, Viridia, Intellivue & MP series monitors 30' Cable Interfaces ECG for HP/ Philips CMS, Viridia, Intellivue & MP series monitors 30' Cable Interfaces BP & ECG for Siemens monitors with 1/4" stereo phone plugs 20' Cable Interfaces BP for Philips Viridia & BP & ECG for Spacelabs PC series monitors 30' Cable Interfaces BP for Philips Viridia & BP & ECG for Spacelabs PC series monitors 20' Cable Interfaces BP for Marquette 7000 series monitors 30' Cable Interfaces BP for Marquette 7000 series monitors 20' Cable Interfaces BP & ECG for Marquette 7000 series monitors 30' Cable Interfaces BP & ECG for Marquette 7000 series monitors 20' Cable Interfaces BP & ECG for GE Marquette monitors 30' Cable Interfaces BP & ECG for GE Marquette monitors 30' Cable Interfaces ECG for Spacelabs PC series monitors with TT-253 plugs Interface Transducer Cable 15' Cable Interfaces Datascope Spectrum ECG only to IABP Low Level Output Cable- Unterminated Low Level Output Cable - Interface to Datascope Monitor Low Level Output Cable - Interface to Philips Monitor Low Level Output Cable - Interface to GE Monitor 15' Cable Interfaces Datascope Spectrum / OR monitors to ECG & IBP Syncs of IABP ECG Patient Cable - 5 Lead - 10' (304.8cm) - IEC ECG Leadwires - 5 Lead - Pinch Type - 50" (127cm) - IEC ECG ESIS Leadwires - 5 Lead - Pinch Type - 50" (127cm) - IEC Cable Assembly, Blood Pressure Transducer Adapter AC line cord - 220V - UK (Type G plug) AC Transport Power Supply Accessory Kit, CARDIOSAVE - IEC CARDIOSAVE Multi-Language Operators Manual DVD Luer Plug, Helium Tank - Reusable - Single Tank Helium Tank - Reusable - Pack of 3 Tanks Helium Tank - Reusable - Pack of 3 Tanks - Empty Helium Tank - UK/ France - Reusable - Pack of 3 Tanks (90 Liter Refillable Helium Tank) 3 Way Stopcock Non -Locking, Male Washer Seal, Battery Pack, Lithium-ion Doppler, Ultrasonic IABP Assembly Dopler 8 MHz Probe Plastic Weather Cover Helium Tank - Disposable - Single Tank - Full Safety Disk Tidal Volume Disk Helium Cylinder Value Knob - Helium Tank - United States Value Knob - Helium Tank - Metric Transport Module Mount Reusable Pressure Transducer - P23XL-1 Recorder Paper - Package of 10 rolls Chart Paper, Thermal Array Recorder, 4 roll starter pack Fiber Optic Cleaning Swabs (qty5) Fiber Optic Connector Cleaner CARDIOSAVE™ Hybrid CARDIOSAVE™ Rescue Helium Refilling Station Battery Charging Station CARDIOSAVE Trainer
Model Identifier(s)
0003-00-0060 0012-00-0323 0012-00-0819-01 0012-00-0819-02 0012-00-0820-01 0012-00-0820-02 0012-00-0821-02 0012-00-0822-01 0012-00-0822-02 0012-00-0823-01 0012-00-0823-02 0012-00-0824-01 0012-00-0824-02 0012-00-0825-01 0012-00-0825-02 0012-00-0826-02 0012-00-1245 0012-00-1459-01 0012-00-1589-01 0012-00-1589-02 0012-00-1589-03 0012-00-1589-04 0012-00-1650-01 0012-00-1812-02 0012-00-1813-02 0012-00-1814-02 0012-00-1815 0012-00-1823-04 0014-00-0085 0020-00-0480-02 0070-CD-0638 0075-00-0024-01 0075-00-0024-03 0075-00-0034-03 0075-02-0001-03 0103-00-0167 0103-00-0717 0146-00-0097 0154-01-0001 0154-01-0005 0198-00-0087 0202-00-0104 0202-00-0140 0202-00-0142 0348-00-0185 0366-00-0092 0366-00-0098 0436-00-0223 0682-00-0084 0683-00-0422-02 0683-00-0422-04 0683-00-0519-02 0683-00-0521-01 0998-00-0800-52 0998-00-0800-83 0998-00-0801 0998-00-0802 0998-00-0803