Edwards Lifesciences LLC

Address:ONE EDWARDS WAY,IRVINE,CA,92614,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

CATHETER, OXIMETER, FIBEROPTIC (DQE) (10) CATHETER, FLOW DIRECTED (DYG) (8) CATHETER, INTRAVASCULAR, DIAGNOSTIC (DQO) (8) Catheter, continuous flush (KRA) (8)

Premarket Exempt

No Yes

Clear

SWAN-GANZ - 00690103000207 Catalog Number : 015F4

Device Description : NON-BALLOON DUAL LUMEN OXIMETRY CATHETER

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQE

Prescription Use : Yes

Device Count : 1

SWAN-GANZ - 00690103000221 Catalog Number : 040F4

Device Description : NON-BALLOON DUAL LUMEN OXIMETRY CATHETER

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQE

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103000245 Catalog Number : 096F6P

Device Description : TRUE SIZE THERMODILUTION CATHETER

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQO, DYG, DQE, KRA

Prescription Use : Yes

Device Count : 1

SWAN-GANZ - 00690103000269 Catalog Number : 110F5

Device Description : SWAN-GANZ DOUBLE LUMEN MONITORING CATHETER

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, KRA, DQE, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103000276 Catalog Number : 111F7P

Device Description : TRUE SIZE CATHETER DOUBLE LUMEN

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQE, DYG, KRA, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103000313 Catalog Number : 114F7P

Device Description : TRUE SIZE MONITORING CATHETER TRIPLE LUMEN

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, DQE, KRA, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103000375 Catalog Number : 123F6P

Device Description : SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, DQE, KRA, DQO

Prescription Use : Yes

Device Count : 1

SWAN-GANZ - 00690103000405 Catalog Number : 131F7P

Device Description : SWAN-GANZ THERMODILUTION CATHETER

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DQO, KRA, DYG, DQE

Prescription Use : Yes

Device Count : 1

SWAN-GANZ TRUE SIZE - 00690103000467 Catalog Number : 132F5

Device Description : SWAN-GANZ TRUE SIZE THERMODILUTION CATHETER

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DYG, DQO, DQE, KRA

Prescription Use : Yes

Device Count : 1

SWAN-GANZ - 00690103000474 Catalog Number : 139F75

Device Description : SWAN-GANZ THERMODILUTION CATHETER

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DYG, DQO, DQE

Prescription Use : Yes

Device Count : 1

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