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Results for Family Left Ventricular Assist Device:


31 Result(s)

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PDF 

HeartMate 3TM  LVAS IFU Addendum – Implant Surgical Techniques Other than Full Median Sternotomy

[PDF 0.16MB] (EN)

LVAS KIT, HM3, HM3 LVAS MINI KIT, PACKAGED ASSEMBLY, OUTFLOW, HM3, APICAL CORING KNIFE, MOD CABLE, STERILE, HM3, ASSEMBLY, TUNNELING LANCE, HM3, HM3 Surgica More
106524US, 10001696, 105581US, 1050, 106525US, 10010372GBL, 10002222US, 28717, 106522US, 106528US, 106532US, 106534US, 106526US, 10012390GBL, 106531US, More
100167359 - A
Effective Begin Date 8/26/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate 3TM  LVAS IFU Addendum – Implant Surgical Techniques Other than Full Median Sternotomy

Products, 40 Total

  • LVAS KIT, HM3
  • HM3 LVAS MINI KIT
  • PACKAGED ASSEMBLY, OUTFLOW, HM3
  • APICAL CORING KNIFE
  • MOD CABLE, STERILE, HM3
  • ASSEMBLY, TUNNELING LANCE, HM3
  • HM3 Surgical Hand Tools
  • Explant Return Kit
  • ASSY, SHELF BOX HM3 APICAL CUFF
  • ASSY, SHELF BOX HM3 SKIN CORING PUNCH
  • ASSY, SHELF BOX HM3 THREAD PROTECTORS
  • ASSY, SHELF BOX HM3 TUNNELING ADAPTER
  • MOD CABLE CAP, (PKG OF 3) HM3
  • Outflow Fixation clip, HeartMate 3
  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP SET
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
See All

HeartMate 3TM  LVAS IFU Addendum – Implant Surgical Techniques Other than Full Median Sternotomy

Reorder/Model Numbers, 40 Total

  • 106524US
  • 10001696
  • 105581US
  • 1050
  • 106525US
  • 10010372GBL
  • 10002222US
  • 28717
  • 106522US
  • 106528US
  • 106532US
  • 106534US
  • 106526US
  • 10012390GBL
  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
  • 103426
  • 103860
See All

PDF HeartMate 3™ LVAS
Mobile Power Unit™ Alarms for Clinicians [PDF 5.17MB] (EN)

HeartMate-MOBILE POWER UNIT,NA More
107754 More
10006143 - A
Effective Begin Date 8/15/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate 3™ LVAS
Mobile Power Unit™ Alarms for Clinicians

Products, 1 Total

  • HeartMate-MOBILE POWER UNIT,NA
See All

HeartMate 3™ LVAS
Mobile Power Unit™ Alarms for Clinicians

Reorder/Model Numbers, 1 Total

  • 107754
See All

PDF HeartMate II Sealed Outflow Bend Relief Addendum [PDF 4.43MB] (EN)

PKG & LABELING SOBR,COLLAR,STERILE More
107315 More
107539 - D
Effective Begin Date 9/17/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate II Sealed Outflow Bend Relief Addendum

Products, 1 Total

  • PKG & LABELING SOBR,COLLAR,STERILE
See All

HeartMate II Sealed Outflow Bend Relief Addendum

Reorder/Model Numbers, 1 Total

  • 107315
See All

PDF HeartMate 3™ LVAS
Alarms for Clinicians [PDF 0.73MB] (EN)

SYSTEM CONTROLLER WITH EBB, HM3, HeartMate-CTRL BTT-11V LI-ION, POWER MODULE, NORTH AMERICA, HeartMate-MOBILE POWER UNIT,NA, AC POWER CORD, MPU, HMII, NA, More
106531US, 106128, 1340, 107754, 107760, 1440, 2465, 2865, 109200, 103426, 103860 More
10006137 - A
Effective Begin Date 6/26/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate 3™ LVAS
Alarms for Clinicians

Products, 11 Total

  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • HM II 14V LI-ION BATTERY CLIP SET
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
See All

HeartMate 3™ LVAS
Alarms for Clinicians

Reorder/Model Numbers, 11 Total

  • 106531US
  • 106128
  • 1340
  • 107754
  • 107760
  • 1440
  • 2465
  • 2865
  • 109200
  • 103426
  • 103860
See All

PDF HeartMate 3™ LVAS Surgical Hand Tools
Instructions for Use [PDF 1.28MB] (EN)

HM3, SURGICAL TOOLS, UNLOCK TOOL, HM3 SURGICAL TOOLS, OUTFLOW PLIERS, OUTFLOW PLIERS,HAND TOOLS,UDI,HM3 More
10001795, 10001913, 10006449 More
10006145 - A
Effective Begin Date 7/31/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate 3™ LVAS Surgical Hand Tools
Instructions for Use

Products, 3 Total

  • HM3, SURGICAL TOOLS, UNLOCK TOOL
  • HM3 SURGICAL TOOLS, OUTFLOW PLIERS
  • OUTFLOW PLIERS,HAND TOOLS,UDI,HM3
See All

HeartMate 3™ LVAS Surgical Hand Tools
Instructions for Use

Reorder/Model Numbers, 3 Total

  • 10001795
  • 10001913
  • 10006449
See All

PDF HEARTMATE II™ LVAS
POCKET GUIDE TO ALARMS FOR CLINICIANS [PDF 0.23MB] (EN)

HeartMate II-PT SUP KT-PKT-EQ, HeartMate II-PT SUP KT-PKT, POCKET CONTRLR PKG,HMII STERILE NA, PKT CNTRL, HM II, STERILE (OUS), POCKET CONTRLR PKG,HMII ST More
B106101, B106102, 106762, 106762OUS, MOD_000000000000106762, MOD_106762OUS, 106128, MOD_000000000000106128, 1340, 1440, 2465, 102808, MOD_000000000000 More
10007222 - A
Effective Begin Date 8/19/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HEARTMATE II™ LVAS
POCKET GUIDE TO ALARMS FOR CLINICIANS

Products, 33 Total

  • HeartMate II-PT SUP KT-PKT-EQ
  • HeartMate II-PT SUP KT-PKT
  • POCKET CONTRLR PKG,HMII STERILE NA
  • PKT CNTRL, HM II, STERILE (OUS)
  • POCKET CONTRLR PKG,HMII STERILE NA
  • HeartMate II-POCKET CTRL,OUS
  • HeartMate-CTRL BTT-11V LI-ION
  • HeartMate-CTRL BTT-11V LI-ION
  • POWER MODULE, NORTH AMERICA
  • UNIVERSAL BATTERY CHARGER, NORTH AM
  • 14 V LI-ION BATTERY
  • SINGLE BATTERY, ENERGIZER
  • SINGLE BATTERY, ENERGIZER
  • HM POWER MODULE 14V PATIENT CABLE
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
  • AC POWER CORD, BRAZIL, PACKAGED
  • AC POWER CORD, NO. AMERICA,PACKAGED
  • HeartMate II-SYSTEM MONITOR
  • HeartMate II-SYSTEM MONITOR
  • HM SYSTEM MONITOR II, CANADA
  • HeartMate II-SYSTEM MONITOR
  • HeartMate-SYSTEM MONITOR
  • DEMO SYSTEM MONITOR
  • HeartMate-SYSTEM MONITOR
See All

HEARTMATE II™ LVAS
POCKET GUIDE TO ALARMS FOR CLINICIANS

Reorder/Model Numbers, 33 Total

  • B106101
  • B106102
  • 106762
  • 106762OUS
  • MOD_000000000000106762
  • MOD_106762OUS
  • 106128
  • MOD_000000000000106128
  • 1340
  • 1440
  • 2465
  • 102808
  • MOD_000000000000102808
  • 103426
  • MOD_000000000000103426
  • 103860
  • 103860BR
  • MOD_000000000000103860
  • 1286
  • 1286A
  • 1286A-CAN
  • 1286A-US
  • 1286C
  • 1286D
  • 1286INT
See All

PDF HeartMate® 14 Volt Li-Ion Battery

INSTRUCTIONS FOR USE

For use Exclusively with the HeartMate II® LVAS [PDF 0.68MB] (EN)

14 V LI-ION BATTERY, 14 V LI-ION BATTERY More
102515, 102515-US More
103770 - E
Effective Begin Date 7/30/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate® 14 Volt Li-Ion Battery

INSTRUCTIONS FOR USE

For use Exclusively with the HeartMate II® LVAS

Products, 2 Total

  • 14 V LI-ION BATTERY
  • 14 V LI-ION BATTERY
See All

HeartMate® 14 Volt Li-Ion Battery

INSTRUCTIONS FOR USE

For use Exclusively with the HeartMate II® LVAS

Reorder/Model Numbers, 2 Total

  • 102515
  • 102515-US
See All

PDF HEARTMATE 3™ CORING TOOL
Instructions for Use [PDF 0.86MB] (EN)

SET CORING TOOL ASSY, HANDLE SPRING,CORING TOOL,APICA HM3, WASHER, PTFE, CORING TOOL,APICA HM3 More
10005373, 10004971, 10004972 More
10006217 - D
Effective Begin Date 8/1/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HEARTMATE 3™ CORING TOOL
Instructions for Use

Products, 3 Total

  • SET CORING TOOL ASSY
  • HANDLE SPRING,CORING TOOL,APICA HM3
  • WASHER, PTFE, CORING TOOL,APICA HM3
See All

HEARTMATE 3™ CORING TOOL
Instructions for Use

Reorder/Model Numbers, 3 Total

  • 10005373
  • 10004971
  • 10004972
See All

PDF HeartMate® Tunneler
Handling Instructions [PDF 0.29MB] (EN)

TRAV, TUNNELER HM II, TRAV, TUNNELER HM II More
102137, MOD_000000000000102137 More
102640 - D
Effective Begin Date 8/15/2019
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate® Tunneler
Handling Instructions

Products, 2 Total

  • TRAV, TUNNELER HM II
  • TRAV, TUNNELER HM II
See All

HeartMate® Tunneler
Handling Instructions

Reorder/Model Numbers, 2 Total

  • 102137
  • MOD_000000000000102137
See All

PDF HeartMate 3TM  Left Ventricular Assist System Instructions For Use with System Monitor II [PDF 44.04MB] (EN)

ASSEMBLY, TUNNELING LANCE, HM3, ASSY, SHELF BOX HM3 APICAL CUFF, ASSY, SHELF BOX HM3 SKIN CORING PUNCH, ASSY, SHELF BOX HM3 THREAD PROTECTORS, ASSY, HM IC More
10010372GBL, 106522US, 106528US, 106532US, 10003491, 10002151, 106534US, 106524US, 10001696, 105581US, 106525US, 106533US, 10002222US, 28717, 106526US More
100169835 - C
Effective Begin Date 9/2/2020
Effective End Date
RevisionType:
View all previous versions To request a previous version, contact Customer Service: customerservice@sjm.com, 855-4ST-JUDE (855-478-5833)

Changes to manuals that are designated as "safety" were made to address safety issues.

HeartMate 3TM  Left Ventricular Assist System Instructions For Use with System Monitor II

Products, 41 Total

  • ASSEMBLY, TUNNELING LANCE, HM3
  • ASSY, SHELF BOX HM3 APICAL CUFF
  • ASSY, SHELF BOX HM3 SKIN CORING PUNCH
  • ASSY, SHELF BOX HM3 THREAD PROTECTORS
  • ASSY, HM ICU COVER, 1-PACK (HM II & HM3)
  • ASSY, HM ICU COVER, 6-PACK (HM II & HM3)
  • ASSY, SHELF BOX HM3 TUNNELING ADAPTER
  • LVAS KIT, HM3
  • HM3 LVAS MINI KIT
  • PACKAGED ASSEMBLY, OUTFLOW (US)
  • MOD CABLE, STERILE, HM3
  • HM3 TUNNELER
  • HM3 Surgical Hand Tools
  • Explant Return Kit
  • MOD CABLE CAP, (PKG OF 3) HM3
  • Outflow Fixation clip, HeartMate 3
  • SYSTEM CONTROLLER WITH EBB, HM3
  • HeartMate-CTRL BTT-11V LI-ION
  • HeartMate-MOBILE POWER UNIT,NA
  • AC POWER CORD, MPU, HMII, NA
  • SINGLE BATTERY - PM
  • HM POWER MODULE 14V PATIENT CABLE
  • AC POWER CORD, NO. AMERICA,PACKAGED
  • CF CARD, INSPECTED AND LABELED
  • HeartMate-CARD READER SANDISK
See All

HeartMate 3TM  Left Ventricular Assist System Instructions For Use with System Monitor II

Reorder/Model Numbers, 41 Total

  • 10010372GBL
  • 106522US
  • 106528US
  • 106532US
  • 10003491
  • 10002151
  • 106534US
  • 106524US
  • 10001696
  • 105581US
  • 106525US
  • 106533US
  • 10002222US
  • 28717
  • 106526US
  • 10012390GBL
  • 106531US
  • 106128
  • 107754
  • 107760
  • 109200
  • 103426
  • 103860
  • 101609
  • 102504
See All

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