- Physicians Office Resource

LARGE ADULT CUFF CUFF SET
DOPPLEX - ACC-VAS-011

Device Description

An automated, battery-powered, portable electronic device designed to calculate the ankle brachial pressure index (ABPI), used in the diagnosis of peripheral vascular disease (PVD), from simultaneous oscillometric measurement of the ankle and brachial blood pressure indices. It typically consists of a control/analysis/display unit with cuffs placed around an arm and one or both ankles; it uses integrated transducers to measure cuff pressure oscillations which represent the fluctuations of pressure in the underlying blood vessels. The device is typically operated by a healthcare professional.

Environmental Conditions

Handling Environment Atmospheric Pressure - millibar

1060.00
860.00

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Handling Environment Temperature - Degrees Celsius

35.00
10.00

Storage Environment Atmospheric Pressure - millibar

1060.00
860.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

50.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JOM

Device Name: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2780

Third Party Flag: Y

Medical Specialty: CV

Device Identifiers

Device Id: 05051968030375

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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