AccessGUDID - DEVICE: 2Mhz Monitoring Transducer

GUDID

Device Identifier (DI) Information

Brand Name: 2Mhz Monitoring Transducer - 8 foot
Version or Model: NA-PRB3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA-PRB3
Company Name: Novasignal Corp.

Primary DI Number: 00850681007153
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078766464 *Terms of Use

Device Description: The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity measurements. The transducer has the following specifications: • 2MHz ± 0.1MHz center frequency • 46mm ± 5mm focal length • 16mm active diameter • Fractional 6dB pulse-echo bandwidth = 60% to 80% • Round-trip insertion loss < 6dB • Impedance 22 ohm +/- 5 ohms, real 0°+/- 15° phase

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36970	Noninvasive vascular ultrasound system probe	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, Ultrasonic, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160442	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d171009d-a4a6-4b2f-bff3-691aefe2f724
Public Version Date: November 03, 2023
Public Version Number: 4
DI Record Publish Date: October 17, 2018