ENDOPHYS HOLDINGS, LLC

Address:1933 E. Levee,Dallas,TX,75207,US

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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

Introducer, Catheter (DYB) (2) Transducer, Pressure, Catheter Tip (DXO) (2) Computer, Blood-Pressure (DSK) (1)

Premarket Exempt

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Endophys Blood Pressure Monitor - 00852004007000 Catalog Number :

Device Description : Device used in the measurement of invasive blood pressure (from one or more site Device used in the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a cannula.

Device Class : 2

Duns Number: 079776997

Premarket Exempt : No

Product Code : DSK

Prescription Use : Yes

Device Count : 1

Endophys Pressure Sensing Sheath Kit-6F - 00852004007017 Catalog Number :

Device Description : The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath wi The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer,a vessel dilator and guidewire. Used in conjunction with the Endophys Blood Pressure Monitor it is used to continuously monitor patient blood pressure during procedure requiring vascular access.

Device Class :

Duns Number: 079776997

Premarket Exempt : No

Product Code : DXO, DYB

Prescription Use : Yes

Device Count : 1

Endophys Pressure Sensing Sheath Kit-6F - 00852004007024 Catalog Number :

Device Class : 2

Duns Number: 079776997

Premarket Exempt : No

Product Code : DYB, DXO

Prescription Use : Yes

Device Count : 1

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