ABI-250 Software, Doppler with 8MHz probe, PVR, 1x10cm cuff, 1x12cm cuff, manual aneroid, carry bag, user manual, quick reference guides.

ABI
simpleABI - ABI-250

Device Description

An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
30.00

Handling Environment Temperature - Degrees Celsius

40.00
10.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
5.00

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: JAF

Device Name: Monitor, Ultrasonic, Nonfetal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

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: 892.1540

Third Party Flag: Y

Medical Specialty: RA

Device Identifiers

Device Id: 00852785008654

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