AccessGUDID - DEVICE: CX5-2E Transducer (04056869005003)

GUDID

Device Identifier (DI) Information

Brand Name: CX5-2E Transducer
Version or Model: 05918102
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0002456 / 59180
Company Name: SIEMENS MEDICAL SOLUTIONS USA, INC.

Primary DI Number: 04056869005003
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 136120750 *Terms of Use

Device Description: No description.

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Extracorporeal ultrasound imaging system transducer, hand-held	An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's body during general-purpose imaging applications. It includes single or multiple element transducer configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to ensure adequate contact with the patient it steers, focuses and detects the ultrasound beam and resulting echoes mechanically or electronically. This GMDN code includes ultrasound imaging transducers used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Extracorporeal ultrasound imaging system transducer, hand-held

An ultrasound imaging transducer that is a hand-held device moved over the intact surface of a patient's body during general-purpose imaging applications. It includes single or multiple element transducer configurations that convert electric voltages into an ultrasound beam. Typically used with coupling gels to ensure adequate contact with the patient it steers, focuses and detects the ultrasound beam and resulting echoes mechanically or electronically. This GMDN code includes ultrasound imaging transducers used with A-mode, B-mode, M-mode, Doppler, colour Doppler (CD), and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
ITX	Transducer, ultrasonic, diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: f80fdf73-7a37-4b93-b473-ad8b63fc8e3e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016