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
00852004007222
GS1

1
079776997 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DXO Transducer, Pressure, Catheter Tip
DYB Introducer, Catheter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Catheter Gauge: 8 French
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Device Record Status

31ccc09c-3543-40be-8332-f5705cb05efa
March 08, 2024
1
February 29, 2024
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00852004007239 5 00852004007222 In Commercial Distribution Shipper
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-469-828-5119
support@endophys.com
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