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Draeger TI500 Globe-Trotter™ Neonatal Transport System - HSA Registration DE0009000

Access comprehensive regulatory information for Draeger TI500 Globe-Trotter™ Neonatal Transport System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0009000 and owned by Draeger Medical Systems, Inc.. The device was registered on April 02, 2012.

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
DE0009000
Draeger TI500 Globe-Trotter™ Neonatal Transport System
HSA Registration Number: DE0009000
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Product Description

The TI500 Globe-Trotter™ Neonatal Transport System is a transport incubator system intended for the transport of high risk premature, low birth weight or critically ill newborns from point of birth to an appropriate center for care of such infants. The means of transportation may take the form of either ground or airborne (rotor or fixed wing) transport. The system is also suitable for either transport or stationary care within the hospital and may be made up of three system components. These components include a frame which houses the incubator and the pneumatic module assembly, and a facility for gas tank storage. The system is arranged to serve as a complete unit for the care of an infant in the need of transportation.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90189030
Registration Information
Registration Number
DE0009000
Registration Date
April 02, 2012
Retention Due Date
April 01, 2026
Product Owner
Short Name
Draeger Medical
Address
3135 Quarry Road, Telford, PA 18969, UNITED STATES
Registrant
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Importer
Address
61 SCIENCE PARK ROAD, THE GALEN, #04-01, SINGAPORE 117525
Model Information
Model Name(s)
GT Dual flow Meter 0-10 LTR GT Oxygen Sensor SG Suction Filter STEPHAN GT Suction Pump w/pwr GT Battery Iris port sleeve, disposable, 100 pcs Expiratory valve for TI 500 Globetrotter, disposable Ventilation circuit, manual reusable Breathing hose MVP-10, reusuable Ventilation circuit, manual, disposable, 20 pcs. Breathing hose for TI 500 Globetrotter, disposable Ventilation system with PEEP, manual disposable O2 sensor for TI 500 Globetrotter, reusable HME filter, compressor inlet TI500-IC Transport System Skin Temperature probe 1, reusuable O2 hood, oxydome Stephan F120 Ventilator without Monitor Stephan F120 Ventilator with Monitor TI 500 Globe-Trotter Transport System TI 500 Globe-Trotter Transport System MVP10 Ventilator without Compressor MVP10 Ventilator with Compressor
Model Identifier(s)
MU01007 MU01011 MU01028 MU01029 MU01050 MU03876 MU04472 MU04765 MU04767 MU04770 MU04771 MU04776 MU04804 MU04991 MU05876 MU06951 MU08394 MU18694 MU18695 MU20508 MU20509 OPC4061 OPC4125