InterCare Vascular Diagnostic Center 300

GUDID B2623000

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.

INTERCARE DX, INC.

Cardiovascular-risk peripheral arterial tonometry system

• Primary Device ID: B2623000
• NIH Device Record Key: 09362584-7216-4478-9741-e7e9345a76e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InterCare Vascular Diagnostic Center
• Version Model Number: Vasocor Model 300
• Catalog Number: 300
• Company DUNS: 780001194
• Company Name: INTERCARE DX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (866) 767-4832
• Email: ecampos@intercare.com

Device Dimensions

• Weight: 142 Pound

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B2623000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011625

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-06-07
• Device Publish Date: 2019-05-07