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30 Mar 2018
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Segmental System Proximal Femoral Component 38mm Offset, Zimmer, Inc. (HSA 600:41/01-008/18/07_54)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-07_54 FSN_Redacted94 KB
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29 Mar 2018
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Gentle Threads Interference Screw, Biomet Orthopaedics (HSA 600:41/01-008/18/06_56)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-06_56 FSN_Redacted340 KB
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29 Mar 2018
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AC2000 Spring Arm, Macquet SAS (HSA 600:41/01-081/18/03_43)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: 6296 1992
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HSA 6004101-081-18-03_43 FSN124 KB
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28 Mar 2018
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BD Vacutainer® Push Button Blood Collection Set/BD Vacutainer® Ultra Touch™ Push Button Blood Collection Set, Becton Dickinson and Company (HSA 600:41/01-003/18/02_45)
Local Contact: Becton Dickinson Holdings Pte Ltd
Contact no./Email: 6690 8423
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HSA 6004101-003-18-02_45 FSN_Redacted342 KB
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27 Mar 2018
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ZNN and M/DN Trauma Guide Wires, Zimmer, Inc. (HSA 600:41/01-008/18/05_40)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-05_40 FSN_Redacted84 KB
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27 Mar 2018
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Philips MultiDiagnost Eleva X-Ray Radiography System, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026/18/13_50)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-13_50 FSN_Redacted495 KB
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27 Mar 2018
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Fabius GS Premium, Tiro, Tiro D-M, MRI, plus, plus XL, Dragerwerk AG & CO KGaA (HSA 600:41/01-063/18/03_54)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 / draeger.sg@draeger.com
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HSA 6004101-063-18-03_54 FSN_Redacted1537 KB
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27 Mar 2018
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CARESCAPE R860 ventilator, Datex-Ohmeda Inc. (HSA 600:41/01-010/18/05_51)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-05_51 FSN_Redacted378 KB
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26 Mar 2018
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Philips Achieva 1.5T, Philips Multiva 1.5T Magnetic Resonance Imaging System, Philips Ingenia 1.5T Magnetic Resonance Imaging System, Philips Medical Systems Nederland B.V. (HSA 600:41/01-026-18-12_71)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-12_71 FSN_Redacted354 KB
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26 Mar 2018
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CP3000 w/ CTS 230V & CP3000 w/o CTS 230V, Sekisui Medical Co. LTD (HSA 600:41/01-005/18/03_57)
Local Contact:Abbott Laboratories Singapore Pte Ltd
Contact no./Email: 6914 8000 / FSN@enquiry@abbott.com
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HSA 6004101-005-18-03_57 FSN_Redacted1331 KB
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22 Mar 2018
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FilmArray® Blood Culture Identification (BCID) Panel, BioFire Diagnostics, LLC (HSA 600:41/01-146/18/04_57)
Local Contact: BioMerieux Singapore Pte Ltd
Contact no./Email: 6801 6700
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HSA 6004101-146-18-04_57 FSN433 KB
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21 Mar 2018
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Stryker® T4 and T5 Togas, Stryker Instruments (HSA 600:41/01-014/18/04_68)
Local Contact: Stryker Singapore Pte Ltd
Contact no./Email: ASEAN.PMS@stryker.com
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HSA 6004101-014-18-04_68 FSN302 KB
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20 Mar 2018
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Rotating IV pole, GE Healthcare (HSA 600:41/01-010/18/04_50)
Local Contact: GE Healthcare Pte Ltd
Contact no./Email: 6277 7668 / svc@ge.com
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HSA 6004101-010-18-04_50 FSN_Redacted355 KB
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20 Mar 2018
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Rythmic Evolution Blue, Mini Rythmic Evolution lockable Blue, Micrel Medical Devices S.A. (HSA 600:41/01-012/18/01_18)
Local Contact: B. Braun Singapore Pte Ltd
Contact no./Email: 6213 0933 / press.sg@bbraun.com
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HSA 6004101-012-18-01_18 FSN_Redacted312 KB
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20 Mar 2018
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iChemVELOCITY Automated Urine Chemistry System, Iris Diagnostics, a Division of Iris International, Inc. (HSA 600:41/01-052/18/02_69)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-18-02_69 FSN_Redacted100 KB
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19 Mar 2018
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Draeger Infinity Acute Care System (IACS) Monitoring Solution, Draeger Medical Systems, Inc. (HSA 600:41/01-063/18/02_36)
Local Contact: Draeger Singapore Pte Ltd
Contact no./Email: 6872 9288 /draeger.sg@draeger.com
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HSA 6004101-063-18-02_36 FSN_Redacted112 KB
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16 Mar 2018
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iQ200 Series Urine Microscopy Analyzer, Iris Diagnostics (HSA 600:41/01-052/18/01_67)
Local Contact: Beckman Coulter Singapore Pte Ltd
Contact no./Email: 6340 7126
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HSA 6004101-052-18-01_67 FSN_Redacted133 KB
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15 Mar 2018
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PERI-LOC VOL DIST RAD LCK PL STD HD 9H SH R 135MM, Smith & Nephew, Inc. (HSA 600:41/01-073/18/06_44)
Local Contact: Smith & Nephew Pte. Ltd.
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-06_44 FSN174 KB
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15 Mar 2018
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HALYARD Closed Suction Kits with Flex Connector, Halyard Health, Inc (HSA 600:41/01-259/18/01_49)
Local Contact: Halyard Singapore Pte Ltd
Contact no./Email: 6350 4330
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HSA 6004101-259-18-01_49 FSN_Redacted6651 KB
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15 Mar 2018
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PERI-LOC K-WIRE 1.6MM X 150MM LENGTH TROCAR POINT, Smith & Nephew, Inc. (HSA 600:41/01-073/18/05_51)
Local Contact: Smith & Nephew Pte Ltd
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-05_51 FSN174 KB
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14 Mar 2018
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Artisan Link, Agilent Technologies Denmark (HSA 600:41/01-086/18/01_69)
Local Contact: SPD Scientific Pte Ltd
Contact no./Email: 6303 9877 / sales@spdscientific.com
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HSA-6004101-086-18-01_69 FSN_Redacted143 KB
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13 Mar 2018
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Gambro Ultrafilter U9000, Gambro Dialysatoren GmbH (HSA 600:41/01-001/18/01_35)
Local Contact: Baxter Healthcare (Asia) Pte Ltd
Contact no./Email: 6826 2616
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HSA 6004101-001-18-01_35 FSN146 KB
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12 Mar 2018
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DxTerityTM Diagnostic Catheter, Medtronic Inc (HSA 600:41/01-009/18/04_64)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-18-04_64 FSN705 KB
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10 Mar 2018
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Ortho-Clinical Diagnostics Biovue® System ABO-Rh/Reverse Grouping Cassette and Ortho-Clinical BioVue® System Anti-IgG Cassette, Ortho-Clinical Diagnostic (HSA 600:41/01-303/18/04_60)
Local Contact: ORTHO-CLINICAL DIAGNOSTICS SINGAPORE PTE. LTD
Contact no./Email: 6486 1151
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HSA 6004101-303-18-04_60 FSN_Redacted435 KB
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09 Mar 2018
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ID-DiaCell I-II-III, DiaMed GmbH (HSA 600:41/01-027/18/02_67)
Local Contact: Bio-Rad Laboratories (Singapore) Pte Ltd
Contact no./Email: 6490 4262
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HSA 6004101-027-18-02_67 FSN_Redacted2425 KB
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08 Mar 2018
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D-RAD Titanium 2.4mm x 10mm Locking Screw T7 Self-Tapping, Smith & Nephew Inc. (HSA 600:41/01-073/18/04_43)
Local Contact: Smith & Nephew Pte. Ltd.
Contact no./Email: singapore.surgicalsale@smith-nephew.com
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HSA 6004101-073-18-04_43 FSN173 KB
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08 Mar 2018
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Acuson SC2000, Siemens Medical Solutions USA, Inc. (HSA 600:41/01-022/18/07_18)
Local Contact: Siemens Healthcare Pte Ltd
Contact no./Email: ui-handling.sg.dl@siemens-healthineers.com
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HSA 6004101-022-18-07_18 FSN190 KB
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07 Mar 2018
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LifePak 1000 Defibrillator, Physio-Control Inc (HSA 600:41/01-056/18/01_37)
Local Contact: Gold Lite Pte Ltd
Contact no./Email: 6273 0487
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HSA 6004101-056-18-01_37 FSN_Redacted100 KB
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07 Mar 2018
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Subset of Medtronic Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Implantable Cardioverter Defibrillators (ICDs), Medtronic Inc (HSA 600:41/01-009/18/03_35)
Local Contact: Medtronic International Limited
Contact no./Email: 6436 5077
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HSA 6004101-009-18-03_35 FSN302 KB
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06 Mar 2018
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Comprehensive Segmental Revision System, Biomet Orthopaedics (HSA 600:41/01-008/18/04_36)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-04_36 FSN_Redacted151 KB
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06 Mar 2018
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Roche Diagnostics cobas® 8000 modular analyzer series - cobas e 801 module, Roche Diagnostics GmbH (HSA 600:41/01-016/18/03_70)
Local Contact: Roche Diagnostics Asia Pacific Pte Ltd
Contact no./Email: sg.regulatory@roche.com
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HSA 6004101-016-18-03_70 FSN1594 KB
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06 Mar 2018
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Agilia Volumat Infusion Lines, Fresenius Vial (HSA 600:41/01-020/18/01_66)
Local Contact: Fresenius Kabi (Singapore) Pte Ltd
Contact no./Email: 6837 2552
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HSA 6004101-020-18-01_66 FSN_Redacted2015 KB
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05 Mar 2018
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Alinity ci-series System Control Module (SCM), Abbott GmbH & Co. KG (HSA 600:41/01-005/18/02_34)
Local Contact: Abbott Laboratories (S) Pte Ltd
Contact no./Email: 6941 8000 / FSN_enquiry@abbott.com
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HSA 6004101-005-18-02_34 FSN110 KB
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02 Mar 2018
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M/L Taper Femoral Stem, Zimmer Inc. (HSA 600:41/01-008/18/03_37)
Local Contact: Zimmer Pte Ltd
Contact no./Email: 6854 7222 / cs.singapore@zimmerbiomet.com
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HSA 6004101-008-18-03_37 FSN_Redacted63 KB
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02 Mar 2018
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Hill-Rom Progressa Bed System, Hill-Rom, Inc. (HSA 600:41/01-182/18/02_71)
Local Contact: Hill-Rom Services Pte Ltd
Contact no./Email: 6499 7395
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HSA 6004101-182-18-02_71 FSN_Redacted246 KB
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01 Mar 2018
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Servo ventilators, Maquet Critical Care AB (HSA 600:41/01-081/18/02_52)
Local Contact: Maquet South East Asia Pte Ltd
Contact no./Email: Tel: 6296 1992
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HSA 6004101-081-18-02_52 FSN_Redacted84 KB
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01 Mar 2018
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Cook Vacuum Pump™/ Cook Aspiration Unit™, William A. Cook Australia Pty Ltd (HSA 600:41/01-013/18/01_68)
Local Contact: Cook South East Asia Pte Ltd
Contact no./Email: 6412 7400 / SNG-RegulatoryAffairs@CookMedical.com
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HSA 6004101-013-18-01_68 FSN_Redacted358 KB
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01 Mar 2018
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Philips Ingenuity Flex, Ingenuity CT, Philips Brilliance Computed Tomography X-Ray System,Philips IQon Spectral CT System, Philips Medical Systems (HSA 600:41/01-026/18/11_64)
Local Contact: Philips Electronics (S) Pte Ltd
Contact no./Email: 1800 744 5477
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HSA 6004101-026-18-11_64 FSN_Redacted524 KB
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22 Jan 2018
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Mako Onlay Insert Extractor, MAKO Surgical Corp. (HSA 600:41/01-070/18/02_25)
Local Contact: Transmedic Pte Ltd
Contact no./Email: 6477 6101 / regulatory@transmedicgroup.com
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HSA 6004101-070-18-02_25 FSN_Redacted113 KB
This updated FSN replaces the original FSN published in January 2018
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