hearX

GUDID 00860003469828

hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).

HEARX GROUP (PTY) LTD

Otoscope, direct

• Primary Device ID: 00860003469828
• NIH Device Record Key: 3a062b74-2e58-4fca-8783-9d232ef4b43b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: hearX
• Version Model Number: hearScope
• 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: true
• Serial Number: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860003469828 [Primary]

FDA Product Code

• ERA: Otoscope

Sterilization

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

[00860003469828]

High-level Disinfectant

[00860003469828]

High-level Disinfectant

[00860003469828]

High-level Disinfectant

[00860003469828]

High-level Disinfectant

[00860003469828]

High-level Disinfectant

[00860003469828]

High-level Disinfectant

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-07
• Device Publish Date: 2022-05-30

On-Brand Devices [hearX]

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