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Draeger Infinity Delta Series - HSA Registration DE0007112

Access comprehensive regulatory information for Draeger Infinity Delta Series in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007112 and owned by Draeger Medical Systems, Inc.. The device was registered on June 22, 2011.

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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HSA Official Data
CLASS C
DE0007112
Draeger Infinity Delta Series
HSA Registration Number: DE0007112
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Product Description

The Monitors are capable of monitoring: Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, Apnea, ST Segment Analysis, 12-lead ST Segment Analysis, tcpO2/tcpCO2, EEG signals, FiO2 and end tidal CO2. Scio gas module sampled breathing gases from adults and pediatrics. The gas module continuously measures the content of CO2, N2O, O2 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the Infinity monitors. The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and Arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Cardiovascular
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0007112
Registration Date
June 22, 2011
Change Notification Approval Date
February 01, 2024
Retention Due Date
June 21, 2025
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)
HOSE NBP 3.7M External airway filter, 10pcs Cable Great Britian, 3m, 10A SpO2 Nellcor OxibandP/I 100pcs Grounding Cable, 5m Neonatal cuff #5, 8.3-15.0cm arm circumference, Latex free, 10pcs Neonatal cuff #1, 3.1-5.7cm arm circumference, Latex free, 10pcs Neonatal cuff #2, 4.3-8.0cm arm circumference, Latex free, 10pcs Neonatal cuff #3, 5.8-10.9cm arm circumference, Latex free, 10pcs Neonatal cuff #4, 7.1-13.1cm arm circumference, Latex free, 10pcs HOSE NBP 2.4M IBP ADAPT 10P TO 7P MULTIMED ECG TEMP SPO2 HEMO POD COM CBL 2/4 SPO2 EXTEN CBL SHLD 1M CO INTERMEDIATE CABLE SPO2 EXTEN CBL SHLD 2M IBP ADP OHMEDA HEMO IBP ADP 10 PIN OR HEMO Interface Plate. R50 Cable, IDS-R50, 3m Y-cable , recorder and alarm output. Recorder cable, 0.6m CBL ANALOG UNTERM 5M Alarm Output Cable, 5m. QRS Sync Cable, 3m. One end unterminated Hemo4 Pod CABLE XMITTER ANALOG EKG ETCO2 MODULE Hemo2 Pod IBP CBL INTRM SENSONOR ACE Full Arrhythmia Option CAPNOSTAT etCO2 SENSOR Hemo pod adapter, SensoNor / Memscap TEMP PROBE SKIN 1.5M Temperature probe, pediatric, 1.5m TEMP PROBE ADULT ECG ELECTRODE DISP 50PC. Dome for SensoNor 840, 50pcs PROBE CERAMIC TPO2/TPCO2 IBP-set disp, SensoNor 840, 10pcs R50 recorder, 10 rolls RS232 Diagnostic UART cable, 3m. ETCO2 CANNULA PED S ETCO2 CANNULA ADULT S ETCO2 NAFION TUBING ETCO2 AIRWAY ADPT SIDE DOCK STN BASE N/C Wall mount adapter for IDS Shelf mount, Docking Station Rail mount for IDS power supply Rolling Stand Bracket for IDS power supply on pole of a rolling stand Wall mount Docking Station Wall-mountable bracket for holding IDS Mount Adapter, monitor + R50 Recorder PLATE HEMO2 TRANSD OHMEDA HEMO4 TRANSD PLATE MED/SEN IBP 4 TRAN PLT IBP 2 TRAN PLT MED/SEN R50 Recorder Cables, IDS-Interface Plate, 1.5m ADAP ETCO2 AIRWAY NEO ADAP ETCO2 AIRWAY ADULT Rolling Stand Docking Station Patch cable, 20m Patch cable, 1.2m Patch cable, 2.4m Patch cable, 4.9m Bed Mount Docking Station Remote Display Cable, 25m MULTIMED-6 ECG TEMP SP IBP 4 TRAN PLT ABT/BRN SURGEON DISPLAY CONTROL Adapter pin, neonatal ECG electrodes, 10pcs CBL CPS TO ISD 25M Alarm Output Cable, 5m. ECG ELECTRODE NEO 300PC Pod Comm cable 5m ADAP HEMO POD BAXTER ADAPT HEMOPOD ABBOTT R50 countertop plate TEMP ADPT 1/4" JACK MIB cable, Siemens Servo Ventilator 300/300A MIB cable, Edwards/Baxter Vigilance/Vigiliance II MIB cable, Puritan Bennett 7200 MIB cable, Siemens Servo Ventilator 900 MIB cable, Dräger Evita 2, Evita 4/Evita XL/Savina/Fabius CE, Babylog ventilators Temperature probe adult, 5m Temperature probe adult, 3m Temp skin probe, adult, 3m Temperature probe pediatric, 1.5m 3-Lead ST Anaylsis Option Physiological Calculation Option TEMP PROBE ADULT 3M TEMP PROBE PEDIATRIC 3M Temperature probe, skin, adult, 3m INFINITY DOCK STATION HEMOMED POD MIB connection cable, 3m 12 LEAD ECG + SPO2 (Multimed 12 Pod) NEOMED SP-FIO2 ECG TMP 16P INTMD HEMOMED 3M HemoMed intermediate cable 5m External Battery Pack (Sealed Lead Acid) IBP Y CABLE 16PIN-7PIN Temp Y-cable (for Multimed) 3 LEAD ECG NEOMED TPO2/CO2 POD Y-cable , IDS to Remote Keypad PodCom Option SW OPT SC8000 4-5 Channels ARIES 12 Lead ST Option Battery Charger FIO2 CABLE NEOMED 5 to 6 channel Option 6 to 8 channel Option IBP Y CABLE 16P-10P DOCK STN INTFC & PWR MIB cable, Dräger Julian, Cicero C (flow support), Cicero EM(color), Fabius GS, Tiro, Primus, Apollo(flow) MIB cable, Dräger Cato, Cicero B, Cicero EM (B/W) EEG INFINITY POD R50-N recorder POD ETCO2 + RESP MECHANICS etCO2 pod CARDIAC OUTPUT T-PIECE 25PC. MIB cable, Abbott Oximetrix 3 MIB cable, AVL Opti CCA MIB cable, VIA V-ABG1 ARIES/PhysioCalcs/Arrhythmia Package MIB cable, BD/Ohmeda CD ESU-BLOCK 5 LEADS EEG REUSABLE LEADS 9EA MULTIMED 5 1.5 METERS MIB cable, Aspect A-2000 BIS Monitor R50 RECORDER UNIVERSAL MIB cable, Siemens Servo EEG Referential Lead Block converter ECG 3LD-GRBR IEC1 ECG cable, 3-lead, dual-pin connector, IEC2 (AHA/US) 1 m ECG cable, 5-lead, dual-pin connector, IEC2 (AHA/US) 1 m ECG 5LD-GRBR IEC1 ECG cable, 6-lead, dual-pin connector, IEC2 (AHA/US) 1 m ECG 6LD-GRBR IEC1 ECG cable for V lead, IEC2 (AHA/US) 1.5 m ECG C-5LD-GRBR Respiratory Mechanics Adapter, disposable, 10pcs Flow Neonatal Respiratory Mechanics Adapter, disposable, 10pcs CO2 + Flow Neonatal Respiratory Mechanics Adapter, disposable, 10pcs CO2 + Flow Adult / Pediatric Respiratory Mechanics Adapter, disposable, 10pcs Flow Adult / Pediatric Respiratory Mechanics Adapter, disposable, 10pcs CO2 + Flow Pediatric Water Trap (set of 12) Scio direct connect cable X8, 1.8m Scio Four Oxi plus Module MIB cable, Dräger Nakomed 2/4, 6000, 6400 Temp protective covers, 10 pcs MIBII PROTO CONV-LS MIB II DUO CONVERTER Pod Comm cable 0.3m SHP OPT MIBII 1-4 DURASENSOR SPO2 DS100A ADULT Cable Management bracket. Mounts under IDS HEMO4 TRANS PLATE ABBT TP IV ESU-BLOCK 6 LEADS INFINITY DOCK STATION CAN/MIB CBL SPO2 EXT PROCAL MAS 2M Radiometer MIB cable, Hamilton Galileo ventilator MIB cable, Taema Horus ventilator MIB cable, Puritan Bennett 840 ventilator MIB cable, Abbott Q2/Q2+ Continuous Cardiac Output/SvO2 Radiometer MIB cable, Hamilton Galileo ventilator MIB cable, Dräger Julian/Apollo/Primus(CO2 support) SpO2 Masimo adh square, 12 pcs SpO2 Masimo FOAMWRAPLNOP 12PC SpO2 Masimo Petite Wrap 100pcs SpO2 Wrap for Masimo LNOP YI SpO2 Posey Wrap Masimo 12pcs Wireless Option Pick and Go EasiArm Mount Kit Temp skin probe pediatric, 10pcs Nasal sampling cannula pediatric 25pcs Nasal sampling cannula adult 25pcs Nasal sampling cannula +O2 pediatric 25pcs Nasal sampling cannula +O2 adult 25pcs Nasal / mouth sampling cannula pediatric 25pcs Nasal / mouth sampling cannula intermediate 25pcs Nasal / mouth sampling cannula adult 25pcs Airway adapter set adult / pediatric 25pcs Airway adapter (for high humidity) set adult / pediatric 25pcs Airway adapter (for high humidity) set infant / neonatal 25pcs Nasal / mouth sampling cannula O2 adult 25pcs Nasal / mouth sampling cannula O2 adult / pediatric 25pcs Nasal / mouth sampling cannula O2 pediatric 25pcs Nasal sampling cannula (high humidity) adult 25pcs Nasal sampling cannula (high humidity) pediatric 25pcs Nasal sampling cannula (high humidity) infant / neonatal 25pcs POD ETCO2 MICROSTR SC7/8/9XL CBL NMT ACCESSORY 1.9M INFINITY TRIDENT SAMPLE LINE SET (10PCS) CO CATHETER CBL CO THERMISTER CBL (Ohmeda) CO THERMISTER CBL - EDW FIO2 CELL WITH O RING HOSE SET (MEAS.GAS FEED-BACK) BIS Pediatric Sensor (set of 25) EEG-Zip Prep electrodes, 75 pcs BIS Quatro Sensor (set of 25) Mounting set for tp sensor CAL 1 calibration gas Electrode holder kit Calibration unit Masimo Adapter Cable LNCS-LNOP ECG cable, 3-lead, single-pin connector, single-pat. use, IEC1 (European color code), 1 m ECG cable, 3-lead, single-pin conn., single-pat. use, IEC2 (AHA/ US color code), 1 m ECG cable, 5-lead, single-pin conn., single-pat. use, IEC1 (European color code), 1/1.5 m ECG cable, 5-lead, single-pin conn., single-pat. use, IEC2 (AHA/ US color code), 1/1.5m Adapter Cable M-LNCS to LNC ECG cable, 6-lead, single-pin connector, single-patient use, IEC1 (European color code), 1/1.5 m ECG cable, 6-lead, single-pin connector, single-patient use, IEC2 (AHA/US color code), 1/1.5 m Adapter Cable M-LNCS to MM Headband for LNOP/LNCS TF-I Adhesive Pad LNOP/LNCS TF-I ECG 3-lead, grabber, 1m, single pin connector, IEC1 (European color code) ECG 3-lead, grabber, 1m, single pin connector, IEC2 (AHA color code) ECG 5-lead, grabber, 1/1.5m, single pin connector, IEC1 (European color code) ECG 5-lead, grabber, 1/1.5m, single pin connector, IEC2 (AHA color code) ECG 6-lead, grabber, 1/1.5m, single pin connector, IEC1 (European color code) ECG 6-lead, grabber, 1/1.5m, single pin connector, IEC2 (AHA color code) ECG 3-lead, grabber, 1m, dual pin connector, IEC1 (European color code) ECG 3-lead, grabber, 1m, dual pin connector, IEC2 (AHA color code) ECG 5-lead, grabber, 1/1.5m, dual pin connector, IEC1 (European color code) ECG 5-lead, grabber, 1/1.5m, dual pin connector, IEC2 (AHA color code) ECG 6-lead, grabber, 1/1.5m, dual pin connector, IEC1 (European color code) ECG 6-lead, grabber, 1/1.5m, dual pin connector, IEC2 (AHA color code) ECG 5-lead C, grabber, 1m, dual pin connector, IEC1 (European color code) ECG 5-lead C, grabber, 1m, dual pin connector, IEC2 (AHA color code) Accessory set for tpO2 / CO2 sensor CBL 2L GRAB NMT 300MM Scio Connecting cable X3, 0.3m Water Trap, disposable, 30pcs Scio Connecting cable X3, 1.5m CBL MASIMO INT SpO2 1.5M CUFF 31-40cm Large Adult CUFF 38-50cm Thigh CUFF 17-25 Small Adult CUFF 23-33cm Adult CUFF 12-19cm Child CUFF 8-13cm Infant ML3 ADULT MM IEC1 ECG cable, 3-lead, single-pin connector MonoLead® 3, IEC2 (AHA/US) 2m ML5 ADULT MM IEC1 ECG cable, 5-lead, single-pin connector MonoLead® 5, IEC2 (AHA/US) 2.5 m Monolead-Multimed Adapter 6/5 Monolead-Multimed Adapter 6/6 ECG cable, 6-lead, single-pin connector MonoLead® 6, IEC2 (AHA/US) 3.1m ML6 ADULT MM IEC1 BISx pod INFINITY TRIDENT POD SYSTEM Export Protocol cable SENSOR NMT THERMISTOR ADAPTER NMT THUMB 50PC ACCELEROMETER NMT HAND ADAPTOR FOR ACCELERATION TRANSDUCER CABLE CLIP LARGE BIS Quatro Sensor Kit (set of 5) BIS pediatric sensor kit (set of 5) C/C HOOK HANDLE DEL/DEL XL CABLE VITAL CONNECTION Cable CNAP Port-Manifold Cuff CNAP Pod Small Cuff CNAP Pod Medium Cuff CNAP Pod - Large ECG 6LD GRAB T IEC1 1M ECG 5LD GRAB T IEC1 1M ECG 3LD GRAB T IEC1 1M CBL ML3 D/PIN IEC1 ML5 D/PIN IEC1 MIB cable, Dräger Fabius GS, Tiro ECG cable, 5-lead, dual-pin connector MonoLead® 5, IEC2 (AHA/US) 2.5m ECG cable for C lead MonoLead® 5, IEC2 (AHA/US) 2.5 m ECG cable, 3-lead, single-pin connector, IEC2 (AHA/US color code), 1 m ML5 D/PIN IEC1 ECG cable, 3-lead, dual-pin connector MonoLead® 3, IEC2 (AHA/US) 2m ECG extension cable, single-pin connector, 2 m Pediatric Disposable Oximetry Sensor, foam Adult Disposable Oximetry Sensor, foam Neonatal Disposable Oximetry Sensor Infant Disposable Oximetry Sensor Pediatric Disposable Oximetry Sensor, vinyl Adult Disposable Oximetry Sensor, vinyl MIB cable, Viasys BEAR 1000/BEAR cub Ventilator CBL EXT 2PIN-2PIN 2M ECG cable, 5-lead, single-pin connector, IEC2 (AHA/US color code), 1 m ECG cable, 6-lead, single-pin connector, IEC2 (AHA/US color code) KIT STARTER PICCO POD KIT SPO2 MASIMO POD DELTA KIT SPO2 MASIMO POD KAPPA Infinity CNAP SmartPod CBL CO INTERM PICCO CBL CO CATHETER PICCO CBL CO THERMISTR PICCO CBL IBP INTRFACE PICCO Scio "Y" cable X8-X3 MIB cable, Dräger Zeus OR Mode (stored in the IDS) CBL SPO2 POD LNOP 3M CUFF 23-33cm Adult Long CUFF 31-40cm Large Adult Long SHP SYS Infinity CNAP Pod ECG MonoLead 6, IEC1 (EURO), 5.7m* SPO2 ADAPTER CBL 3M POD PICCO 3M CBL SPO2 POD LNCS 3M OR Mode SRS Sensor Kit (set of 100 sensor sets and 1 reusable cable) Power adapter (IDS power supply) PWR SUPPLY G/GXL/V Infinity Delta XL Infinity Delta SpO2 intermediate cable Masimo LNOP, 1.2 m SPO2 ADAPTER CBL 1.2M MIB cable, Dräger Caleo, C2000/C2000E incubators and Babytherm warmer Infinity Kappa MULTIMED PLUS MULTIMED PLUS OR ProCal + Intermediate cable, 2 m Baxter/Edwards, transducer adaptor cable Argon/Becton Dickinson, transducer adaptor cable Dräger 10-pin Transducer Adapter Cable (Adapter cable to connect PULSION disposable pressure transducers to the PiCCO Pod). Dräger 7-pin, transducer adaptor cable Utah Medical, transducer adaptor cable Abbott-Medex, (Transtar) transducer adaptor cable INFINITY PICCO SMARTPOD GEN2 CNAP SmartPod NELLCOR OXIMAX SPO2 PD SpO2 intermediate cable Masimo LNCS, 1.2 m MIB cable, Somanetics INVOS 5100C MIB cable, DatexOhmeda/GE Aestiva/Aespire 7900/7100 802.11. b/g wireless card PCMCIA wireless card adaptor Nellcor OxiMax Sensors Inf/Neo Nellcor OxiMax Sensors Adt/Ped ECG neonatal 3-lead adapter cable, 2 m Arm Strap Generation 2 SHP ASY CNAP GEN2 CO2 MICROSTR N/M CAN ADT/INT CO2 MICROSTR N/M CAN+O2 AD/INT ECG MonoLead 3, IEC2 (AHA/US), 4.1m* ECG MonoLead 5, IEC2 (AHA/US), 5.3m* ECG MonoLead 5, IEC1 (EURO), 5.3m* ECG MonoLead 6, IEC2 (AHA/US), 5.7m* ECG MonoLead 3, IEC1 (EURO), 4.1m* EEG Electrodes Disposable, 25 Pieces INFINITY PICCO SMARTPOD GEN2 KIT SpO2 Adhes.Sens.Max A 24pcs. SpO2 Adhesive Sensors Max P SpO2 Adhesive Sensors Max I SpO2 Adhesive Sensors Max N SpO2 Adhesive Sensors Max AL
Model Identifier(s)
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