SWAN-GANZ CCOMBO 746F8

GUDID 00690103002881

SWAN-GANZ CCOMBO THERMODILUTION CATHETER

Edwards Lifesciences LLC

Pulmonary artery catheter, thermal dilution
Primary Device ID00690103002881
NIH Device Record Key406683e1-1c83-4c2e-8a12-5e5c53663cc8
Commercial Distribution StatusIn Commercial Distribution
Brand NameSWAN-GANZ CCOMBO
Version Model Number746F8
Catalog Number746F8
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
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

Device Dimensions

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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.
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.
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
GS100690103002881 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYGCATHETER, FLOW DIRECTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-12-11
Device Publish Date2016-09-03

On-Brand Devices [SWAN-GANZ CCOMBO]

00690103002881SWAN-GANZ CCOMBO THERMODILUTION CATHETER
00690103002850SWAN-GANZ CCOMBO THERMODILUTION CATHETER

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