DD-II 770R Display Digital Doppler with recharger (main unit only)

DD
DigiDop - DD-770R

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 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: LXE

Device Name: Doppler, Fetal, Ultrasound

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: 884.2660

Third Party Flag: Y

Medical Specialty: OB

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: 00852785008975

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