Terumo Cardiovascular Systems 824370

GUDID 10817278010788

Vessel Cannula

Alliant Enterprises, LLC

Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor Cardioplegia solution administration adaptor

• Primary Device ID: 10817278010788
• NIH Device Record Key: 349e676a-600a-4d5b-8496-225c2c4b8c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Terumo Cardiovascular Systems
• Version Model Number: 824370
• Catalog Number: 824370
• Company DUNS: 121170653
• Company Name: Alliant Enterprises, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817278010781 [Primary]
GS1	10817278010788 [Package]; Contains: 00817278010781; Package: Case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K971019

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

[10817278010788]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-05
• Device Publish Date: 2016-09-23

On-Brand Devices [Terumo Cardiovascular Systems]

• 00817278012402: BlowMister
• 10817278012003: BlowMister
• 10817278011464: Cardiac Sucker, flexible, fluted tip, 1/4" connector, 14.5" length
• 10817278011457: Mini rigid cardiac sucker, soft tip w/ side ports, 1/4" connector, 9" length
• 10817278011440: Antegrade Cardioplegia Cannula 14Ga(7Fr) w/VentLine & Insertion Needle 16ga
• 10817278011433: Antegrade Cardioplegia Cannula 12Ga(9Fr) w/VentLine & Insertion Needle 14ga
• 10817278011426: Antegrade Cardioplegia Cannula, 14Ga (7Fr), with Insertion Needle, 16Ga
• 10817278011419: Antegrade Cardioplegia Cannula, 12Ga (9Fr), with Insertion Needle, 14Ga
• 10817278011396: Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length
• 10817278011372: Retrograde Cardioplegia Cannula, Self Inflating Balloon (18mm) and Rigid Stylet
• 10817278010863: Retrograde Cardioplegia Cannula, Self Inflate, Textured Balloon, Rigid Stylet, Sure Touch, Long,
• 10817278010856: Retrograde Cardioplegia Cannula, Self Inflate, Med Balloon, Rigid Stylet, Sure Touch, Long, 15Fr
• 10817278010849: Retrograde Cardioplegia Cannula, Manual Inflate, Smooth Balloon, Rigid Stylet, 15Fr
• 10817278010832: Retrograde Cardioplegia Cannula, Self Inflate, Med Balloon, Guidwire Stylet, 15Fr
• 10817278010825: Retrograde Cardioplegia Cannula, Self Inflate, Textured Balloon, Rigid Stylet, Sure Touch, Long,
• 10817278010818: RCC, Self Inflate, Med Balloon, Rigid Stylet, Sure Touch, 15Fr
• 10817278010801: Retrograde Cardioplegia Cannula, Manual Inflate, Textured Balloon, Stopcock, Guidewire, 15Fr
• 10817278010795: Retrograde Cardioplegia Cannula, Manual Inflate, Smooth Balloon, Guidewire Stylet, 15Fr
• 10817278010788: Vessel Cannula
• 10817278010771: Multi-Perfusion Adapter with Vent
• 10817278010764: Multi-Perfusion Adapter
• 10817278010757: Y Vent Adapter
• 10817278010740: Y Perfusion Adapter
• 10817278010733: Recirculation Adapter
• 10817278010726: Vented Adapter