Terumo Cardiovascular Systems 820355

GUDID 10817278010795

Retrograde Cardioplegia Cannula, Manual Inflate, Smooth Balloon, Guidewire Stylet, 15Fr

Alliant Enterprises, LLC

Cardioplegia cannula

• Primary Device ID: 10817278010795
• NIH Device Record Key: 27515e30-7c79-4962-9202-18766d5b8d1d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Terumo Cardiovascular Systems
• Version Model Number: 820355
• Catalog Number: 820355
• 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	00817278010798 [Primary]
GS1	10817278010795 [Package]; Contains: 00817278010798; Package: Case [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964199

FDA Product Code

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

Sterilization

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

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

Ethylene Oxide

[10817278010795]

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