THRUPORT SYSTEMS ENDOVENT PULMONARY CATHETER KIT EV

GUDID 00690103182866

ENDOVENT PULMONARY CATHETER KIT

Edwards Lifesciences LLC

Chamber-decompression cardiac catheter
Primary Device ID00690103182866
NIH Device Record Key40d9ff13-1ead-4edd-98ff-899f6fa8f406
Commercial Distribution StatusIn Commercial Distribution
Brand NameTHRUPORT SYSTEMS ENDOVENT PULMONARY CATHETER KIT
Version Model NumberEV
Catalog NumberEV
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100690103182866 [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

Devices Manufactured by Edwards Lifesciences LLC

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50690103197902 - TRUCLIP2025-07-23 TRUCLIP
50690103210823 - Combo Kits2025-07-23 Pressure Monitoring Set
00690103216998 - HEMOSPHERE2025-07-23 Mindray OEM Pressure Smart Cable
00690103219111 - Cable2025-07-23 PHILIPS CARDIAC OUTPUT TEMPERATURE PROBE
07460691949867 - PRESSURE MONITORING ACCESSORY2025-07-23 PRESSURE MONITORING ACCESSORY
57460691956143 - TruWave2025-07-23 PRESSURE MONITORING ACCESSORY

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