FDA.reportPublic FDA data

Endophys Pressure Sensing Sheath Kit - 6F 12 CM

Primary DI
00852004007062
Brand
Endophys Pressure Sensing Sheath Kit - 6F 12 CM
Company
ENDOPHYS HOLDINGS, LLC
Model
PSS-30-0612200-SCN
Device description
The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic 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 procedures requiring vascular access.
Published
2023-10-27
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
10852004007069PackageGS15In Commercial Distribution
00852004007062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085200400706910852004007069
00852004007062008520040070628520040070620852004007062

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 Gauge6French

Contacts#

Phone, Email table
PhoneEmail
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
00852004007222Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No GuidewirePSS-10-0811200-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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403524618TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524717TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524779TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524809TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524847TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524946TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525462TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525486TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403527411TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
08498840011300VYGONVygon CorporationDYB2019-04-08
08498840011317VYGONVygon CorporationDYB2019-04-08
08498840011751VYGONVygon CorporationDYB2019-04-08
08498840011768VYGONVygon CorporationDYB2019-04-08
08498840011775VYGONVygon CorporationDYB2019-04-08
08498840011782VYGONVygon CorporationDYB2019-04-08
08498840011799VYGONVygon CorporationDYB2019-04-08
08498840011805VYGONVygon CorporationDYB2019-04-08
08498840011812VYGONVygon CorporationDYB2019-04-08
08498840012215VYGONVygon CorporationDYB2019-04-08
H965481030ENVINAVILYST MEDICAL, INC.DYB2019-01-03
07613327459210AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459227AXS VECTA 71Stryker CorporationDYB2018-10-26
07613327459234AXS VECTA 71Stryker CorporationDYB2018-10-26
H965481080NavylistNAVILYST MEDICAL, INC.DYB2017-08-07
H965355010ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355020ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355030ENVINAVILYST MEDICAL, INC.DYB2017-08-07
H965355060ENVINAVILYST MEDICAL, INC.DYB2017-08-07