IOP8 - DEMO KIT 2

IOP8
DOPPLEX - IOP8-DK2-USA

Device Description

A hand-operated component of an invasive vascular ultrasound system intended to be used perioperatively to measure the flow of blood in an isolated blood vessel, by being applied to the outside of the vessel, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a reusable device.

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: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Ethylene Oxide

Moist Heat or Steam Sterilization
Ethylene Oxide

Product Codes

Code: ITX

Device Name: Transducer, Ultrasonic, Diagnostic

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: 892.1570

Third Party Flag: Y

Medical Specialty: RA

Device Identifiers

Device Id: 05051968020154

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

IOP8 - DEMO KIT 2 - USA