FDA.reportPublic FDA data

Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire

Primary DI
00852004007222
Brand
Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire
Company
ENDOPHYS HOLDINGS, LLC
Model
PSS-10-0811200-SCN-NGW
Device description
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.
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXOTransducer, Pressure, Catheter Tip
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXOTransducer, Pressure, Catheter TipCardiovascular2
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852004007239PackageGS15In Commercial Distribution
00852004007222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852004007239008520040072398520040072390852004007239
00852004007222008520040072228520040072220852004007222

GMDN Terms#

Term, Definition table
TermDefinition
Catheter-tip transducer, pressureA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge8French

Contacts#

Phone, Email table
PhoneEmail
1-469-828-5119support@endophys.com

Regulatory Flags#

DUNS number
079776997
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852004007208Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No GuidewirePSS-30-0612200-SCN-NGW2024-02-29
00852004007215Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No GuidewirePSS-30-0612200-SCN-NGW2024-02-29
00852004007239Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No GuidewirePSS-10-0811200-SCN-NGW2024-02-29
00852004007017Endophys Pressure Sensing Sheath Kit-6FPSS-20-0612200-ECN2016-11-18
00852004007024Endophys Pressure Sensing Sheath Kit-6FPSS-20-0612200-SCN2017-04-10
00852004007031Endophys Pressure Sensing Sheath Kit - 8F 11 CMPSS-10-0811200-SCN2023-10-27
00852004007062Endophys Pressure Sensing Sheath Kit - 6F 12 CMPSS-30-0612200-SCN2023-10-27
00852004007079Endophys Pressure Sensing Sheath Kit - 8F 25 CMPSS-10-0825200-SCN2023-10-27
00852004007086Endophys Pressure Sensing Sheath Kit - 8F 11 CMPSS-10-0811200-SCN2023-10-27
10852004007069Endophys Pressure Sensing Sheath Kit - 6F 12 CMPSS-30-0612200-SCN2023-10-27
10852004007076Endophys Pressure Sensing Sheath Kit - 8F 25 CMPSS-10-0825200-SCN2023-10-27
00852004007000Endophys Blood Pressure MonitorBPM-20-SC2016-09-22

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Primary DI, Brand, Company table
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