FDA.reportPublic FDA data

Endophys Pressure Sensing Sheath Kit-6F

Primary DI
00852004007017
Brand
Endophys Pressure Sensing Sheath Kit-6F
Company
ENDOPHYS HOLDINGS, LLC
Model
PSS-20-0612200-ECN
Device description
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.
Published
2016-11-18
Public version status
Update
Distribution status
Not 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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141275000ENDOPHYS PRESSURE SENSING SHEATH KITEndophys, Inc.2015-01-07DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852004007018PackageGS15In Commercial Distribution
00852004007017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852004007018008520040070188520040070180852004007018
00852004007017008520040070178520040070170852004007017

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079776997
Device count
1
Kit
true
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
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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