ThruPort Systems QuickDraw Venous Cannula with Insertion Kit QD25

GUDID 00690103182705

ThruPort Systems QuickDraw Venous Cannula

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, venous
Primary Device ID00690103182705
NIH Device Record Keyf7260eb5-8a7e-475c-8b13-8b61a6070827
Commercial Distribution StatusIn Commercial Distribution
Brand NameThruPort Systems QuickDraw Venous Cannula with Insertion Kit
Version Model NumberQD25
Catalog NumberQD25
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

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
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 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
GS100690103182705 [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 QuickDraw Venous Cannula with Insertion Kit]

00690103182705ThruPort Systems QuickDraw Venous Cannula
00690103182699ThruPort Systems QuickDraw Venous

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.