HIGH SENSITIVITY 8MHZ WIDE BEAM
DOPPLEX - EZ8XS-USA
Device Description
A hand-operated component of a noninvasive vascular ultrasound system intended to be placed on the surface of a patient's body to measure the flow of blood in the underlying vasculature using ultrasonic/Doppler/transit time technology. It may include single or multiple element transducer configurations that convert electric voltages into an ultrasound beam reproducing movement and flow graphically, typically with sound. The device is available in various frequency capacities (e.g., 4, 5, or 8 MHz). It may also be used to detect the foetal heartbeat. This is a reusable device.
Environmental Conditions
- 1060.00
- 700.00
- 93.00
- 15.00
- 40.00
- 5.00
- 1060.00
- 700.00
- 93.00
- N/A
- 35.00
- 5.00
- 5.00
- -25.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 IdentifiersDevice Id: 05051968041326
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