Endophys Pressure Sensing Sheath Kit - 8F 11 CM

GUDID 00852004007086

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 procedures requiring vascular access.

ENDOPHYS HOLDINGS, LLC

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Primary Device ID00852004007086
NIH Device Record Key14ba2b77-dbcc-4b7a-be7c-3915b5e86e62
Commercial Distribution StatusIn Commercial Distribution
Brand NameEndophys Pressure Sensing Sheath Kit - 8F 11 CM
Version Model NumberPSS-10-0811200-SCN
Company DUNS079776997
Company NameENDOPHYS HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com
Phone469-828-5119
Emailsupport@endophys.com

Device Dimensions

Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French
Catheter Gauge8 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100852004007031 [Primary]
GS100852004007086 [Package]
Contains: 00852004007031
Package: [5 Units]
In Commercial Distribution

FDA Product Code

DXOTransducer, Pressure, Catheter Tip

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-06
Device Publish Date2023-10-27

Devices Manufactured by ENDOPHYS HOLDINGS, LLC

00852004007215 - Endophys Pressure Sensing Sheath Kit - 6F 12 CM, No Guidewire2024-03-08 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer
00852004007239 - Endophys Pressure Sensing Sheath Kit - 8F 11 CM, No Guidewire2024-03-08 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer
00852004007086 - Endophys Pressure Sensing Sheath Kit - 8F 11 CM2023-11-06The 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 procedures requiring vascular access.
00852004007086 - Endophys Pressure Sensing Sheath Kit - 8F 11 CM2023-11-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer
10852004007069 - Endophys Pressure Sensing Sheath Kit - 6F 12 CM2023-11-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic transducer, a vesse
10852004007076 - Endophys Pressure Sensing Sheath Kit - 8F 25 CM2023-11-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer
00852004007000 - Endophys Blood Pressure Monitor2018-07-06 Device used in the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introd
00852004007017 - Endophys Pressure Sensing Sheath Kit-6F2018-07-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer
00852004007024 - Endophys Pressure Sensing Sheath Kit-6F2018-07-06 The Endophys Pressure Sensing Sheath Kit is comprised of an introducer sheath with an integrated fiber optic pressure transducer
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