AccessGUDID - DEVICE: Siemens (04056839030042)

GUDID

Device Identifier (DI) Information

Brand Name: Siemens
Version or Model: UNITY 3 COUPLER (REFURBISHED)
Catalog Number: 10933234
Company Name: SIVANTOS, INC.

Primary DI Number: 04056839030042
Issuing Agency: GS1
Device Count: 1

Device Description: Siemens UNITY 3 COUPLER (REFURBISHED)

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

GMDN Preferred Term Name	GMDN Definition
Audiometric/hearing aid tester	An electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit that connect to a computer that runs application software to provide results and graphics (which may be stored in a database). The control unit may also be connected to other manufacturer's test boxes, or run as an audiometer or real-ear-measurement instrument without the test box.

GMDN Preferred Term Name

GMDN Definition

Audiometric/hearing aid tester

An electroacoustic device intended to be used for the evaluation of hearing loss (audiometer function), the evaluation of hearing aids while worn to assure optimal amplification (real-ear measurement), and/or for other hearing aid analysis (functions as the hearing aid analyser to check its proper function when this is being fitted to the patient). It typically consists of a test box and a control unit that connect to a computer that runs application software to provide results and graphics (which may be stored in a database). The control unit may also be connected to other manufacturer's test boxes, or run as an audiometer or real-ear-measurement instrument without the test box.

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

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 Status

Commercial Distribution Status: Not in Commercial Distribution
DI Record Publish Date: May 08, 2016
Commercial Distribution End Date: April 05, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: Siemens (04056839030042)