Endophys Pressure Sensing Sheath Kit - 8F 25 CM

FDA UDI

Class II (US FDA UDI)

by Endophys Holdings, Llc

Identity

Trade Name: Endophys Pressure Sensing Sheath Kit - 8F 25 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, and a vessel dilator . 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-10-0825200-SCN FDA UDI
Description: The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer, and a vessel dilator . 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: 00852004007079 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 25 CM by Endophys Holdings, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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OptoWire — Opsens · Class II
PrimeWire Prestige Pressure Guide Wire 185cm JTIP — Volcarica S.R.L. · Class II
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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 3ecc350f-073d-4269-b66b-5e71615353e0 35 fields · synced Jun 8, 2026