Endophys Pressure Sensing Sheath Kit-6F

Basic Information

• Brand Name: Endophys Pressure Sensing Sheath Kit-6F
• Primary DI: 00852004007017
• Version / Model: PSS-20-0612200-ECN
• Company Name: ENDOPHYS HOLDINGS, LLC
• Labeler DUNS: 079776997
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-18
• Public Version: 6
• Public Version Date: 2024-02-02
• Public Version Status: Update
• Public Device Record Key: a7ad1570-baaa-4bab-9d53-da47348a9349
• Distribution End Date: 2017-09-20

Device 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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXO	Transducer, Pressure, Catheter Tip	Cardiovascular	870.2870	2
DYB	Introducer, Catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15071	Catheter-tip transducer, pressure	A device intended to be incorporated into the distal end of a catheter (not included) to measure pressure. It typically consists of a pressure sensor (e.g., a flexible membrane or diaphragm) and a means to convert the detected pressure into electronic signals or possibly ultrasonic signals which are transmitted via a cable or wireless to an external parent device (e.g., a manometer) that processes the signals and displays the results. It is used for invasive measurement of pressure in places such as the central and/or peripheral vasculature, cranium, uterus (typically during labour), pleura, and also in the urinary bladder/urethra (e.g., during urodynamic tests). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852004007017	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K141275	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French