FDA.reportPublic FDA data

Endophys Blood Pressure Monitor

Primary DI
00852004007000
Brand
Endophys Blood Pressure Monitor
Company
ENDOPHYS HOLDINGS, LLC
Model
BPM-20-SC
Device description
Device used in the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a cannula.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSKComputer, Blood-Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSKComputer, Blood-PressureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141615000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141615000ENDOPHYS BLOOD PRESSURE MONITOREndophys, Inc.2015-01-07DSK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852004007000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852004007000008520040070008520040070000852004007000

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood pressure, invasiveA small unit dedicated to the measurement of invasive blood pressure (from one or more sites) obtained through a pressure transducer introduced directly into a blood vessel via a catheter. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the blood pressure parameter/information measured and provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-40 Degrees Celsius65 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079776997
Device count
1
Serial number
true
Manufacturing 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
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

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