Identity
- Trade Name
- InterCare Vascular Diagnostic Center FDA UDI
- Generic Name
- Cardiovascular-risk peripheral arterial tonometry system FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- Vasocor Model 300 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 300 FDA UDI
- Primary DI / UDI-DI
- B2623000 FDA UDI
- 510(k) Number
- K011625 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Cardiovascular-risk peripheral arterial tonometry system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Weight — 142 Pound FDA UDI
Category: Cardiovascular-risk peripheral arterial tonometry system
InterCare Vascular Diagnostic Center by Intercare Dx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Intercare Dx, Inc.
Sources (1)
- FDA UDI 09362584-7216-4478-9741-e7e9345a76e4 37 fields · synced May 29, 2026