SHOEBOX AUDIOMETRY

GUDID B348SHOEBOXAUDIOMETER0

SHOEBOX Ltd

Pure-tone audiometer Pure-tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer Tone audiometer

• Primary Device ID: B348SHOEBOXAUDIOMETER0
• NIH Device Record Key: 26d86c9c-195b-4018-8230-e09d05f347a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHOEBOX AUDIOMETRY
• Version Model Number: SHOEBOXAUDIOMETER
• Company DUNS: 256535894
• Company Name: SHOEBOX 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: 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
HIBCC	B348SHOEBOXAUDIOMETER0 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-25
• Device Publish Date: 2016-09-20

On-Brand Devices [SHOEBOX AUDIOMETRY]

• B348SHOEBOXAUDIOMETER0: SHOEBOXAUDIOMETER
• B835SHOEBOXAUDIOMETER0: SHOEBOXAUDIOMETER