Endophys Pressure Sensing Sheath Kit - 8F 11 CM

FDA UDI

Class II (US FDA UDI)

by Endophys Holdings, Llc

Identity

Trade Name: Endophys Pressure Sensing Sheath Kit - 8F 11 CM FDA UDI
Generic Name: Catheter-tip transducer, pressure FDA UDI
Device Name: 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 procedures requiring vascular access. FDA UDI
Model / Reference: PSS-10-0811200-SCN FDA UDI
Description: 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 procedures requiring vascular access. FDA UDI

Identifiers

Primary DI / UDI-DI: 00852004007031 FDA UDI
FDA Product Code: DXO FDA UDI
DYB FDA UDI
GMDN Term: Catheter-tip transducer, pressure FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2870 FDA UDI
870.1340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Gauge — 8 French FDA UDI

Category: Catheter-tip transducer, pressure

Endophys Pressure Sensing Sheath Kit - 8F 11 CM by Endophys Holdings, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Catheter-tip transducer, pressure.

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OptoWire — Opsens · Class II
PressureWire™ — ST. JUDE MEDICAL, INC. · Class II
OptoWire — Opsens · Class II
PrimeWire Prestige Pressure Guide Wire 185cm JTIP — Volcarica S.R.L. · Class II
PressureWire™ — LIGHTLAB IMAGING, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Endophys Holdings, Llc

Sources (1)

FDA UDI 14ba2b77-dbcc-4b7a-be7c-3915b5e86e62 35 fields · synced May 30, 2026