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) (6) Catheter, Continuous Flush (KRA) (3) Catheter, continuous flush (KRA) (3) Transducer, Pressure, Catheter Tip (DXO) (3)

Premarket Exempt

No Yes

Clear

TRUWAVE, VAMP PLUS - 07460691959149 Catalog Number : T451703A

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959217 Catalog Number : PXMK2330

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959224 Catalog Number : PXMK2331

Device Description : PRESSURE MONITORING KIT - STERILE

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959354 Catalog Number : PXMK2122

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

VAMP - 07460691959415 Catalog Number : 48VMP106

Device Description : BLOOD MANAGEMENT SYSTEM

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP - 07460691959439 Catalog Number : PXVK0458

Device Description : PRESSURE MONITORING SET

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959453 Catalog Number : PXMK1476

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 - 07460691959477 Catalog Number : T001691M

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP PLUS - 07460691959484 Catalog Number : T430023M

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE X 3 (3 CC)/VAMP PLUS (215 CM) - 07460691959491 Catalog Number : T100671M

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : KRA, DXO

Prescription Use : Yes

Device Count : 1

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