DEVICE: Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire (00852004007222)
Device Identifier (DI) Information
Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire
PSS-10-0811200-SCN-NGW
In Commercial Distribution
ENDOPHYS HOLDINGS, LLC
PSS-10-0811200-SCN-NGW
In Commercial Distribution
ENDOPHYS HOLDINGS, LLC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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FDA Product Code
[?]Product Code | Product Code Name |
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DXO | Transducer, Pressure, Catheter Tip |
DYB | Introducer, Catheter |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Catheter Gauge: 8 French |
Device Record Status
31ccc09c-3543-40be-8332-f5705cb05efa
March 08, 2024
1
February 29, 2024
March 08, 2024
1
February 29, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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00852004007239 | 5 | 00852004007222 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-469-828-5119
support@endophys.com
support@endophys.com