DIA FOOT KIT-USA MULTI DOPLX PLUS

DIA FOOT KIT
DOPPLEX - DFK1-USA-MD2-P

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 Atmospheric Pressure - millibar

1060.00
860.00

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Handling Environment Temperature - Degrees Celsius

30.00
10.00

Storage Environment Atmospheric Pressure - millibar

1060.00
860.00

Storage Environment Humidity - Percent (%) Relative Humidity

93.00
N/A

Storage Environment Temperature - Degrees Celsius

40.00
-10.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: KNG

Device Name: Monitor, Ultrasonic, Fetal

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OB

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: 884.2660

Third Party Flag: Y

Medical Specialty: OB

Device Identifiers

Device Id: 05051968017642

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