Edwards Lifesciences Vent Caps SPC2063

GUDID 00690103036206

Vent Caps

Edwards Lifesciences LLC

Catheter orifice occluder
Primary Device ID00690103036206
NIH Device Record Key25f67d01-ffa9-4b8a-8317-99c7a1ddfa74
Commercial Distribution StatusIn Commercial Distribution
Brand NameEdwards Lifesciences Vent Caps
Version Model NumberSPC2063
Catalog NumberSPC2063
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103036206 [Primary]
GS150690103036201 [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 Date2018-07-06
Device Publish Date2016-08-31

Devices Manufactured by Edwards Lifesciences LLC

00690103019063 - HEART VALVE HANDLE ACCESSORY2024-10-28 HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV
50690103019242 - DISPOSABLE HANDLE FOR VALVES/SIZERS2024-10-28 DISPOSABLE HANDLE FOR VALVES/SIZERS
00690103019339 - HEART VALVE ACCESSOR2024-10-28 HANDLE,F/USE W/C-E PHYSIO RING MODEL 4450 N/S
00690103166989 - HEART VALVE ACCESSOR2024-10-28 MITRAL SIZER HANDLE
00690103177701 - A HANDLE COMPATIBLE WITH RING HOLDERS MODELS 5100, 4900, 4100, 4200, 4450 AND 462024-10-28 RING HANDLE - EXTENDED 4"
00690103186437 - FLEXIBLE HANDLE2024-10-28 FLEXIBLE HANDLE
00690103210132 - MITRIS Handle 1140M2024-10-28 11400M valve handle
00690103217773 - Edwards EVOQUE Loading System2024-10-11 Edwards EVOQUE Loading System

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