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) (5) TRANSDUCER, PRESSURE, CATHETER TIP (DXO) (3)

Premarket Exempt

No Yes

Clear

TruWave, VAMP - 07460691959507 Catalog Number : T001744M

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP - 07460691959514 Catalog Number : T00174M

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 - 07460691959521 Catalog Number : T005050M

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE, VAMP JR - 07460691959576 Catalog Number : T470411M

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959613 Catalog Number : 593WSC

Device Description : PRESSURE MONITORING ACCESSORY

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959620 Catalog Number : MFNVC

Device Description : PRESSURE MONITORING ACCESSORY

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959651 Catalog Number : 59L3WSC

Device Description : PRESSURE MONITORING ACCESSORY

Device Class :

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TRUWAVE - 07460691959958 Catalog Number : T100209B

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO

Prescription Use : Yes

Device Count : 1

TruWave, VAMP - 07460691959972 Catalog Number : T310845A

Device Description : PRESSURE MONITORING SET

Device Class : 2

Duns Number: 134139174

Premarket Exempt : No

Product Code : DXO, KRA

Prescription Use : Yes

Device Count : 1

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