Endophys Pressure Sensing Sheath Kit-6F

GUDID 00852004007024

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.

ENDOPHYS HOLDINGS, LLC

Catheter-tip transducer, pressure

• Primary Device ID: 00852004007024
• NIH Device Record Key: 53d663a6-4be2-49eb-8491-de644fb82b8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endophys Pressure Sensing Sheath Kit-6F
• Version Model Number: PSS-20-0612200-SCN
• Company DUNS: 079776997
• Company Name: ENDOPHYS HOLDINGS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com
• Phone: 1-469-828-5119
• Email: support@endophys.com

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852004007024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141275

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-10

On-Brand Devices [Endophys Pressure Sensing Sheath Kit-6F]

• 00852004007024: The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated
• 00852004007017: The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated