SWAN-GANZ TRUE SIZE 123F6P

GUDID 00690103000375

SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

Edwards Lifesciences LLC

Pulmonary artery catheter, thermal dilution Pulmonary artery catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, thermal dilution Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical Pulmonary artery balloon catheter, electrical
Primary Device ID00690103000375
NIH Device Record Key6990a38f-47bb-4e83-a2f1-57c260ed4437
Commercial Distribution StatusIn Commercial Distribution
Brand NameSWAN-GANZ TRUE SIZE
Version Model Number123F6
Catalog Number123F6P
Company DUNS134139174
Company NameEdwards Lifesciences LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS100690103000375 [Primary]
GS150690103000370 [Package]
Package: Shipper [5 Units]
In Commercial Distribution

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 TRUE SIZE]

00690103197310SWAN-GANZ POLYMER BLEND TORQUE SUPPORT TRUE SIZE T-TIP TD CATHETER
00690103018295SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F
00690103017236SWAN-GANZ TRUE SIZE MONITORING "S" TIP CATHETER
00690103000566SWAN-GANZ TRUE SIZE THERMODILUTION "S" TIP
00690103000467SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER
00690103000375SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
00690103000313TRUE SIZE MONITORING CATHETER TRIPLE LUMEN
00690103000276TRUE SIZE CATHETER DOUBLE LUMEN
00690103000245TRUE SIZE THERMODILUTION CATHETER
00690103198645SWAN-GANZ TRUE SIZE THERMODULTION CATHETER, 5F
00690103198638SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER
00690103198584SWAN-GANZ THERMODILUTION "S" TIP

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