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Endophys Pressure Sensing Sheath Kit-6F

FDA UDI

Class II (US FDA UDI)

by Endophys Holdings, Llc

Identity

Trade Name
Endophys Pressure Sensing Sheath Kit-6F 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 procedure requiring vascular access. FDA UDI
Model / Reference
PSS-20-0612200-ECN 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 procedure requiring vascular access. FDA UDI

Identifiers

Primary DI / UDI-DI
00852004007017 FDA UDI
510(k) Number
K141275 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Catheter Gauge — 6 French FDA UDI

Endophys Pressure Sensing Sheath Kit-6F by Endophys Holdings, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endophys Holdings, Llc

Sources (1)

  • FDA UDI a7ad1570-baaa-4bab-9d53-da47348a9349 37 fields · synced Jun 1, 2026