PROBE,2MHZ,HS

PROBE,2MHZ,HS
DOPPLEX - OP2-HS

Device Description

A hand-operated component of a foetal Doppler system intended to be placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow typically as sound. The device is available in various frequency capacities (e.g., 2 or 3 MHz). 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: 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: 05051968022912

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