InterCare Vascular Diagnostic Center

Primary DI
B2623000
Brand
InterCare Vascular Diagnostic Center
Company
INTERCARE DX, INC.
Model
Vasocor Model 300
Catalog number
300
Device description
The InterCare Vascular Diagnostic Center (Model 300) is a mains electricity (AC-Powered) Vascular laboratory that integrates, into one device, various modules that provide indices of significance to peripheral vascular and cardiovascular function. These modules includes Patient Data, Framingham and BMI, ABIgram(tm) Ankle/Brachial Index, PADogram(tm) Segmental Pressure Analysis, Vasogram(tm) Arterial Compliance procedure and Endogram(tm) Endothelial dysfunction measurement (poor vasodilatory response) through the noninvasive measurement of arterial pulsatile volume changes in the arm of a patient during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). InterCare Vascular Diagnostic Center Model 300 also offers administrative capabilities such as creating periodic system usage reports which show test dates, procedures performed, patient names and physician name. Physically, the system consists of hardware and electronics housed in a cart with four wheels. The device includes a computer board, pneumatic circuit, monitor, keyboard, joystick, printer, tubing, blood pressure cuffs, and power cord. It also incorporates Colin Medical Instruments' Oscillometric blood pressure module M1050, a standard high-end, off-the shelf-NIBP system which has passed UL and SP-10 testing.
Published
2019-05-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSystem, Measurement, Blood-Pressure, Non-Invasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011625000VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)Vasocor, Inc.2002-01-23DXN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B2623000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular-risk peripheral arterial tonometry systemAn electrically-powered assembly of devices designed to assess peripheral artery endothelial dysfunction (poor vasodilatory response) and/or arterial stiffness through the noninvasive measurement of arterial pulsatile volume changes in the fingertip during a reactive hyperemia test (occlusion of blood flow followed by abrupt release). It typically includes a dedicated bio-sensor applied to a finger or arm and a computer/software-controlled device used to process, store, display, and help analyse peripheral arterial tone (PAT) data received from the sensor. Endothelial dysfunction is a recognized marker of sub-clinical arteriosclerosis which is used as a predictor of cardiovascular events.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight142Pound

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(866) 767-4832ecampos@intercare.com

Regulatory Flags#

DUNS number
780001194
Device count
1
Serial number
true

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