AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094199420)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901031
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 39400-NP
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094199420
Issuing Agency: GS1
Commercial Distribution End Date: April 24, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: Welch Allyn OAE Hearing Screener with Charging Stand, Bluetooth Wireless and USB Connectivity, Single Use Ear Tip Starter Kit -- 3 mm to 15 mm sizes (#39420), Calibration Certificate, and Data Manager Software; 100- 240 V, 50-60 Hz AC, Lithium-Ion Integrated Battery; IEC Plug Type-B, -C, -G, and -I

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?
41184	Tone audiometer, manual	An electroacoustic device designed to measure the hearing threshold of a patient by presenting tones of increasing or decreasing intensity through headphones to establish the level at which the patient first becomes aware of the sounds. Changes in tone intensity, frequency, and the recording of patient responses are all performed manually.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	AUDIOMETER

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: 02e389b1-51d4-451e-a538-2c2c16230dfd
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016