hearX

GUDID 00860003469811

HEARX GROUP (PTY) LTD

Pure-tone audiometer

• Primary Device ID: 00860003469811
• NIH Device Record Key: 81a9e130-2689-4c53-bcf4-ab4bac49bd52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hearX
• Version Model Number: hearTest
• Company DUNS: 539177681
• Company Name: HEARX GROUP (PTY) LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003469811 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-12
• Device Publish Date: 2020-05-04

On-Brand Devices [hearX]

• 00860003469811: hearTest
• 00860003469828: hearScope consists of a handheld video otoscope with a light source and ear speculum of various