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

TRANSDUCER, PRESSURE, CATHETER TIP (DXO) (9) Catheter, continuous flush (KRA) (3) Transducer, Pressure, Catheter Tip (DXO) (1)

Premarket Exempt

No Yes

Clear

TRUWAVE, VAMP - 07460691958340 Catalog Number : PXVK2W4IV

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958357 Catalog Number : PX278C

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958364 Catalog Number : PXMK2298

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958371 Catalog Number : T531900A

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958395 Catalog Number : PX266C

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP PLUS - 07460691958425 Catalog Number : PXVP1089

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP PLUS - 07460691958449 Catalog Number : PXVP3X3DZ

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958531 Catalog Number : PXMK2306

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958548 Catalog Number : PXMK2307

Device Description : PRESSURE MONITORING KIT

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691958555 Catalog Number : PXMK2308

Device Description : PRESSURE MONITORING KIT

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

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