Edwards Lifesciences EZ Glide Aortic Cannula EZC21TA

GUDID 00690103174199

EZ GLIDE Aortic Cannula

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, arterial
Primary Device ID00690103174199
NIH Device Record Key5ee46e81-db25-45c4-95fd-acde5c761992
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdwards Lifesciences EZ Glide Aortic Cannula
Version Model NumberEZC21TA
Catalog NumberEZC21TA
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com
Phone+1(800)822-9637
Emailtech_support@edwards.com

Device Dimensions

Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
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Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE
Special Storage Condition, SpecifyBetween 0 and 0 *STORE IN A COOL, DRY PLACE

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103174199 [Primary]
GS150690103174194 [Package]
Package: Shipper [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-11
Device Publish Date2016-08-31

On-Brand Devices [Edwards Lifesciences EZ Glide Aortic Cannula]

00690103714418EZ GLIDE Aortic Cannula
00690103714401EZ GLIDE Aortic Cannula
00690103175097EZ GLIDE Aortic Cannula
00690103175080EZ GLIDE Aortic Cannula
00690103175073EZ GLIDE Aortic Cannula
00690103175066EZ GLIDE Aortic Cannula
00690103174199EZ GLIDE Aortic Cannula
00690103174182EZ GLIDE Aortic Cannula
00690103172126EZ GLIDE Aortic Cannula
00690103172119EZ GLIDE Aortic Cannula
00690103172102EZ GLIDE Aortic Cannula
00690103172096EZ GLIDE Aortic Cannula

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