AccessGUDID - DEVICE: Manual VRA Response Box (00817020020396)

GUDID

Device Identifier (DI) Information

Brand Name: Manual VRA Response Box
Version or Model: M020300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INTELLIGENT HEARING SYSTEMS CORP.

Primary DI Number: 00817020020396
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154870455 *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):	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?
61427	Visual-reinforcement-audiometry reward system	An assembly of mains electricity (AC-powered) devices intended to be used in conjunction with an audiometer to reward an infant/child during instrumentation conditioned reflex audiometry/play audiometry. It includes hardware (e.g., monitor, lights) intended to give the child a visual reward, and dedicated operating software; it may include additional controls (e.g., foot-switch) and toys. It is intended to be operated by the healthcare professional to build the conditioned response during auditory testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K900096	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: c2bad1f1-f43b-4191-85e0-f2b2b1e02460
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016