USA DIG DOPPLER-FIXED 3MHZ PROBE

USA DIG DOPPLER
SONICAID - SR3-USA

Device Description

A portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

Environmental Conditions

Handling Environment Atmospheric Pressure - millibar

1060.00
700.00

Handling Environment Humidity - Percent (%) Relative Humidity

93.00
15.00

Handling Environment Temperature - Degrees Celsius

40.00
5.00

Storage Environment Atmospheric Pressure - Degrees Celsius

50.00
35.00

Storage Environment Humidity - Degrees Celsius

5.00
-25.00

Storage Environment Humidity - Degrees Celsius

35.00
5.00

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: 05051968041418

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