ThruPort Systems EndoReturn Arterial Cannula Kit ER23B

GUDID 00690103191417

Arterial Cannula Kit

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, arterial
Primary Device ID00690103191417
NIH Device Record Keya43f013c-a7ce-443b-ad4c-1ff91b718665
Commercial Distribution StatusIn Commercial Distribution
Brand NameThruPort Systems EndoReturn Arterial Cannula Kit
Version Model NumberER23B
Catalog NumberER23B
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 Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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
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
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

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.
Special Storage Condition, SpecifyBetween 0 and 0 *Store sterile packaged device in a cool dry place.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103191417 [Primary]

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 Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [ThruPort Systems EndoReturn Arterial Cannula Kit]

00690103191417Arterial Cannula Kit
00690103191400Arterial Cannula Kit

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