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Draeger Infinity Acute Care System (IACS) - HSA Registration DE0007748

Access comprehensive regulatory information for Draeger Infinity Acute Care System (IACS) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0007748 and owned by Draeger Medical Systems, Inc.. The device was registered on October 11, 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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CLASS C
DE0007748
Draeger Infinity Acute Care System (IACS)
HSA Registration Number: DE0007748
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Product Description

The Inifinity Acute Care System (IACS): The IACS is intended for multi-parameter, physiologic patient monitoring of adult, pediatric, and neonatal patients in environments where patient care is provided by trained healthcare professionals. The IACS obtains the physiologic, multi-parameter data from the connection to the M540 monitor and optional medical devices and displays. The transfer of this data is accomplished by the Infinity network. The Infinity M540 (M540) is intended for the monitoring of multi-parameter, physiologic patient information obtained from connected hardware in environments where patient care is provided by trained healthcare professionals. The M540 is intended to monitor one patient at a time. The M540 and any connected hardware are not intended for use in the following hospital environments: – Hyperbaric chambers – Environments containing MRI equipment

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0007748
Registration Date
October 11, 2011
Change Notification Approval Date
November 25, 2024
Retention Due Date
October 10, 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)
Adult/child NIBP intermediate hose 3.7 m (12.15 ft) OxiBand Oxi-P/I, ped/inf, 100 pieces Desktop 120W power supply Neonatal cuff #5 (8.3–15.0 cm / 3.2–6 in) Neonatal cuff #1 (3.1–5.7 cm / 1.2–2.2 in) Neonatal cuff #2 (4.3– 8.0 cm / 1.7–3.1 in) Neonatal cuff #3 (5.8–10.9 cm / 2.3–4.3 in) Neonatal cuff #4 (7.1–13.1 cm / 2.8–5.1 in) Neonatal NIBP intermediate hose, 2.4 m (7.87 ft) CO Intermediate Cable, 1M Hemo Pod Adapter, Argon Hemo/Picco Pod Adapter, 10Pin Temperature skin probe, 1.5 m (4.9 ft) Pediatric probe, 1.5 m (4.9 ft) Adult probe, 1.5 m (4.9 ft) ECG electrode KittyKat 300 pieces Pod Adapter (Edwards) Pod Adapter (Abbott/Medex) Temperature adapter cable Adult probe, 3 m (9.8 ft) Pediatric probe, 3 m (9.8 ft) Temperature skin probe, 3 m (9.8 ft) Dual temperature Y cable, 7-pin CO Thermistor T-Piece, 25 pcs. CO2 Test gas cylinder CO2-Kuevette ERW CO2-Kuevette Paed. Test filter MCable - Mainstream CO2 Infinity® MCable-Microstream™ CO2 extension cable Durasensor DS-100A, adult, finger Cardiac Ouput Kit Baxter  Cardiac Output Kit Argon Universal pole mount Adhesive SpO2 square, 12 pieces Clothing clip, 5 pieces SpO2 Masimo FoamwrapLNOP 12pc Petite wrap-Adult/Pedi/Neo SpO2 Wrap for Masimo LNOP YI Sensor tape replacement, 100 pieces Posey wrap, 12 pieces Pediatric probe, 1.5 m (4.9 ft) and cover, 10 pieces Nellcor Oxiband wrap A/N, 100 pieces Calibration Set CO2 Standby holder w/o calibration Infinity PS50 CO Catheter to Interm. Cable CO Thermistor Cable, Argon CO Thermister Cbl, Edwards Infinity C700 cockpit Infinity C700 for IT Nellcor intermediate cable, 1.2 m (3.9 ft) TC-I adult ear YI adult/pediatric/infant/neonatal multi-site Adtx, adult, 20 pieces Inf/Inf-3, infant, 20 pieces Neo/Neo-3, neonatal, 20 pieces Pdtx, pediatric, 20 pieces NeoPt/NeoPt-3, preterm 20 pieces DCIP pediatric digit DCI adult digit Masimo intermediate cable, LNCS 3 m (9.8 ft) TF-I adult forehead Masimo intermediate cable, LNCS 1.2 m (3.9 ft) ECG Grabber 3-lead, IEC1 (Europe), 1 m (3.3 ft) ECG Grabber 3-lead, IEC2 (AHA/US), 1 m (3.3ft) ECG Grabber 3-lead, IEC1 (Europe), 1m/1.5m (3.3 ft/ 4.9ft) ECG Grabber 3-lead, IEC2 (AHA/US), 1 m /1.5m (3.3ft/4.9ft) Infant arm cuff, 8–13 cm (3–5 in) Child arm cuff, 12–19 cm (5–7 in) Small adult arm cuff, 17–25 cm (6–10 in) Adult arm cuff, 23–33 cm (9–13 in) Adult arm cuff, 23–43 cm (9–17 in) Adult arm cuff, 23–53 cm (9–21 in) Large adult arm cuff, 31–40 cm (12–16 in) Large adult arm cuff, 31–55 cm (12–21 in) Large adult thigh cuff, 38–55 cm (15–21 in) Infant arm cuff, 8–13 cm (3–5 in) Child arm cuff, 12–19 cm (5–7 in) Small adult arm cuff, 17–29 cm (6–11 in) Adult arm cuff, 23–33 cm (9–13 in) Adult arm cuff, 23–43 cm (9–17 in) Adult arm cuff, 23–53 cm (9–21 in) Adult arm cuff, 31–43 cm (12–17 in) Adult arm cuff, 31–55 cm (12–21 in) Adult arm cuff, 38–50 cm (15–10 in) Extension hose, adult Spu GP Temp Probe Adult 1.6m Spu GP Temp Probe Adult 3.0m Spu GP Temp Probe Ped 1.6m Spu GP Temp Probe Ped 3.0m SPU SKIN TEMP PROBE ADULT 1.6M SPU SKIN TEMP PROBE ADULT 3.0M SPU SKIN TEMP PROBE PED 1.6M SPU SKIN TEMP PROBE PED 3.0M Disposable CO2 Cuvette Adult Disposable CO2 Cuvette paed. Rainbow Sensor R25, 10 pcs - disposable Rainbow Sensor R20, 10 pcs- disposable Rainbow Sensor R25-L, 10 pcs - disposable Rainbow Sensor R20-L, 10 pcs - disposable Rainbow Sen Adult Sample Pack- disposable Rainbow Sen Ped/Inf SamplePack- disposable Rainbow Sensor DCI Adult - reusable Rainbow Sensor DCIP Pediatric-reusable Rainbow Cable RC-4, 1.2m Rainbow Cable RC-12, 3.6m SpO2 Masimo M-LNCS Adtx-3, 20p- disposable SpO2 Masimo M-LNCS Pdtx-3, 20p- disposable SpO2 Masimo M-LNCS Inf-3, 20p- disposable SpO2 Masimo M-LNCS Neo-3, 20p- disposable SpO2 Masimo M-LNCS NeoPt-3, 20p- disposable SpO2 Masimo M-LNCS DCI Adult- reusable SpO2 Masimo M-LNCS DCI Pedi-reusable SpO2 Masimo M-LNCS TC-I Ear-reusable SpO2 Masimo M-LNCS YI Multis-reusable SpO2 Masimo M-LNCS TC-I Adult-reusable SpO2 Masimo M-LNCS Sample Pack- disposable SpO2 Masimo M-LNC-4-Cable 1.2m- intermediate cable SpO2 Masimo M-LNC-10 Cbl 3m- intermediate cable SpO2 Masimo RedLNC-4 Cbl 1.2m -intermediate cable SpO2 Masimo RedLNC-10 Cbl 3m- intermediate cable SpO2 Masimo Sen LNCS DBI Adult-reusable Rainbow Sen ReSposable R2-25a Rainbow Sen ReSposable R2-20a Single Pat use ECG 4-lead IEC1 Single Pat use ECG 4-lead IEC2 Single Pat use ECG 6-lead IEC1 Single Pat use ECG 6-lead IEC2 rainbow sensor, ReSposable R2-25 starter pack, adult (contains 1 reusable R2-25r sensor plus 3 R2-25a disposable adhesive sensors) rainbow sensor, ReSposable R2-20 starter pack, pediatric (contains 1 reusable R2-20 sensor plus 3 R2-20a disposable adhesive sensors) Masimo TraumaSen.LNCS Adt- disposable Masimo TraumaSen.LNCS Neo-- disposable Masimo TraumaSen.LNCS Inf/Ped-- disposable Masimo Cable 4.3m, LNC- intermediate cable SpO2 Masimo RedLNC-14 Cbl 4.3m- intermediate cable Headband for LNOP/LNCS TF-I Adhesive Pad LNOP/LNCS TF-I Rainbow Sen ReSposable System R2-25 Rainbow Sen ReSposable System R2-20 Rainbow Sen ReSposable System R2-25r Rainbow Sen ReSposable System R2-20r Masimo Rainbow sensor shield Masimo TraumaSen.M-LNCS Neo- disposable Masimo TraumaSen.M-LNCS Inf/Ped- disposable Masimo TraumaSen.M-LNCS Adt- disposable SpO2 Masimo M-LNCS DBI Adult-reusable SpO2 Masimo M-LNC-14 Cbl 4.3m- intermediate cable ECG 3-Lead single-pin Euro, 1m ECG 3-Lead single-pin AHA, 1m ECG 5-lead single-p Euro, 1.5m ECG 5-lead single-p AHA, 1.5m ECG 6-lead single-p Euro, 1.5m ECG 6-lead single-p AHA, 1.5m ECG 4-lead Chest Euro, 1m ECG 4-Lead Chest AHA/US, 1m ECG MonoLead 3-lead, IEC1 (Europe), 2m (6.5 ft) ECG MonoLead 3-lead, IEC2 (AHA/US), 2 m (6.5 ft) ECG MonoLead 5-lead, IEC1 (Europe), 5.3m (17.4 ft) ECG MonoLead 5-lead, IEC2 (AHA/US), 2.5m (8.2 ft) ECG MonoLead 6-lead, IEC2 (AHA/US), 3 m (10 ft) Monolead 6, Euro, 3M ECG MonoLead 4-lead, IEC1 (Europe), 1.7 m (5.6 ft) ECG MonoLead 4-lead, IEC2 (AHA/US),1.7 m (5.6 ft) ECG grabber 6-lead, IEC1 (Europe), 1 m (3.3 ft) ECG grabber 5-lead, IEC1 (Europe), 1 m (3.2 ft) ECG grabber 3-lead, IEC1 (Europe), 1 m (3.3 ft) ECG grabber 3-lead, IEC2 (AHA/US), 1 m, (3.3 ft) ECG extension cable 3/5/6, 2 m (6.5 ft) SHP OPT S/W M540 Wireless ECG grabber 5-lead, IEC2 (AHA/US), 1 m, (3.3 ft) ECG grabber 6-lead, IEC2 (AHA/US), 1 m, (3.3 ft) ECG Cbl Monolead 6, Euro 5.7m Infinity M540 Infinity M500 Docking Station ECG MonoLead 4-lead, IEC2 (AHA/US), 3.7m (12.1 ft) ECG MonoLead 4-lead, IEC1 (Europe), 3.7m (12.1 ft) SHP OPT S/W Multi-IBP SHP OPT S/W IACS 10-12 Channel SHP OPT S/W IACS 12-16 Channel SHP OPT S/W IACS 12 Lead SHP OPT S/W IACS ITWEB SLITSCN SHP OPT S/W IACS IT WEB TAB SHP OPT S/W IACS View Editor SHP OPT S/W IACS Physio Calcs Infinity MCable - Analog/Sync Infinity MCable - Masimo SET Infinity MCable - Nellcor OxiMax Infinity MPod - Quad Hemo 120W Power Supply Infinity MCable-Dual Hemo Nellcor intermediate cable, 3 m (9.8 ft) Transd Cable Baxter/Edwards Transducer Cable Argon SHP OPT S/W IACS Full Arrhyth Y-Cbl CO2 and Analog/Sync Infinity P2500 ECG grabber 4-lead, IEC2 (AHA/US) 1 m (3.3 ft) ECG grabber 4-lead, IEC1 (Europe), 1 m (3.3 ft) Transducer Cable Drager 10-Pin Transducer Cable Draeger 7 Pin Transducer Cable Utah Medical Transducer Cable Abbott/Medex ECG "4-lead" spacer, 10 pieces SHP EXC M540 Nellcor SHP EXC PS250 Hemo Pod Adapter Sensonor 7Pin M540 Hemo Connect Cable 1.5m M540 Hemo Connect Cable 2.9m IACS monitoring with C500 IACS monitoring with C700 SHP EXC M540 Masimo ECG neonatal 3-lead adapter cable, 2 m (6.5 ft), single pin Infinity MCable - Masimo Rainbow SET Masimo Rainbow SET MCable ECG Cbl Monolead 3 AHA/US 4.1M ECG Cbl Monolead 5 AHA/US 5.3M ECG Cbl Monolead 5, Euro,5.3m ECG Cbl Monolead 6 AHA/US 5.7m ECG Cbl Monolead 3, Euro, 4.1m Infinity Nellcor Mount Kit Infinity Masimo SET Mount Kit Infinity Rainbow Mount Kit SW OPT Rainbow SpHb SW OPT Rainbow SpMet SW OPT Rainbow SpCO SW OPT Rainbow PVI SW OPT Rainbow SpOC 4 Lead ECG Extension Cbl 2m Infinity M540 Infinity® MCable-Microstream™ CO2 Infinity® MCable-Microstream™ CO2 holder Infinity® MCable-Microstream™ CO2 pole mount adapter SHP EXC M540 WCM MCable-Microstream CO2 kit CABLE SCIO/M540 2.2M CABLE SCIO/M540 0.8M CABLE SCIO/M500 0.8M CABLE SCIO/M500 2.2M Dura-Y SpO2 Sensor (reusable) OxiMax MAX-A, 46 cm (18 in) cable, 24 pieces OxiMax MAX-P, pediatric, 24 pieces OxiMax MAX-I, infant, 24 pieces OxiMax MAX-N, neo/adult, 24 pieces SpO2 Adhes.Sens.Max R 24pcs SpO2 Adhes.Sens.MaxFast 24pcs. OxiMax MAX-AL, 91 cm (36 in) cable, 24 pieces
Model Identifier(s)
1275275 2170221 2606270 2870173 2870181 2870199 2870207 2870215 2870298 3368458 3375941 3375958 4329822 4329848 4329889 5195024 5196980 5196998 5198333 5204644 5204651 5204669 5592154 5741975 6850435 6870279 6870280 6870281 6871950 6872159 7262764 7265155 7265163 7485621 7496875 7496883 7496891 7496909 7496917 7496925 7496933 7498921 8201012 8412710 8416352 8416800 8419160 8420077 8539983 MK31701 MK31710 MP00748 MP00788 MP00789 MP00790 MP00791 MP00792 MP00793 MP00794 MP00795 MP00796 MP00797 MP00799 MP00800 MP00875 MP00877 MP00879 MP00881 MP00911 MP00912 MP00913 MP00915 MP00916 MP00917 MP00918 MP00919 MP00921 MP00924 MP00925 MP00926 MP00928 MP00929 MP00930 MP00931 MP00932 MP00934 MP00953 MP00991 MP00992 MP00993 MP00994 MP00995 MP00996 MP00997 MP00998 MP01062 MP01063 MP02959 MP02960 MP02961 MP02962 MP02963 MP02964 MP02971 MP02972 MP02974 MP02975 MP02976 MP02977 MP02978 MP02979 MP02980 MP02981 MP02982 MP02983 MP02984 MP02985 MP02986 MP02988 MP02989 MP02991 MP02992 MP02993 MP02997 MP02998 MP03120 MP03121 MP03122 MP03123 MP03131 MP03132 MP03191 MP03192 MP03193 MP03194 MP03196 MP03197 MP03198 MP03199 MP03200 MP03201 MP03202 MP03203 MP03204 MP03205 MP03206 MP03207 MP03208 MP03401 MP03402 MP03403 MP03404 MP03405 MP03406 MP03407 MP03408 MS14555 MS14556 MS14559 MS14560 MS14682 MS14683 MS14693 MS14694 MS16157 MS16158 MS16159 MS16231 MS16256 MS16266 MS16546 MS16547 MS17185 MS20401 MS20407 MS20475 MS20476 MS20504 MS20505 MS20506 MS20508 MS20511 MS20512 MS20515 MS20516 MS20662 MS20667 MS20668 MS20725 MS20749 MS20783 MS20979 MS22147 MS22148 MS22225 MS22259 MS22277 MS22364 MS22365 MS22532 MS22533 MS22534 MS22535 MS22832 MS22956 MS22957 MS23598 MS23897 MS23898 MS25510 MS25520 MS25643 MS25951 MS27003 MS27900 MS28557 MS28558 MS28559 MS28560 MS28561 MS28963 MS28964 MS28965 MS28967 MS28968 MS28969 MS28970 MS28972 MS31435 MS31818 MS32641 MS32642 MS32774 MS32955 MS33160 MS33167 MS33168 MS33986 MS33987 MX01004 MX50065 MX50066 MX50067 MX50068 MX50069 MX50070 MX50071