SHOEBOX Audiometry

GUDID B835SHOEBOXAUDIOMETER0

SHOEBOX Ltd

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• Primary Device ID: B835SHOEBOXAUDIOMETER0
• NIH Device Record Key: e3389526-f892-4373-bebe-4134f99ed68b
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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 [Previous]
HIBCC	B835SHOEBOXAUDIOMETER0 [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: 2
• Public Version Date: 2023-08-03
• Device Publish Date: 2020-05-28

On-Brand Devices [SHOEBOX Audiometry]

• B348SHOEBOXAUDIOMETER0: SHOEBOXAUDIOMETER
• B835SHOEBOXAUDIOMETER0: SHOEBOXAUDIOMETER