Headphone HDA 300

GUDID 04260223142482

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223142482
• NIH Device Record Key: 737d94a4-dc5f-4cc7-b152-e171036fe309
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Headphone HDA 300
• Version Model Number: 100630
• Company DUNS: 551540334
• Company Name: PATH medical GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260223142482 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133012

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: 2018-07-06
• Device Publish Date: 2016-08-31

Devices Manufactured by PATH medical GmbH

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• 04260223146596 - Ear Tip ET-LT45G Pack/100 pcs.: 2023-11-22
• 04260223146619 - Ear Tip ET-LT50G Pack/100 pcs.: 2023-11-22
• 04260223146633 - Ear Tip ET-LT60M Pack/100 pcs.: 2023-11-22
• 04260223146978 - Ear Tip PM007H Pack/100 pcs.: 2023-11-22 7 mm mushroom ear tip, hard version
• 04260223146985 - Ear Tip PM011H Pack/100 pcs.: 2023-11-22 11 mm mushroom ear tip, hard version
• 04260223146992 - Ear Tip PM012H Pack/100 pcs.: 2023-11-22 12 mm mushroom ear tip, hard version
• 04260223147005 - Ear Tip PM013H Pack/100 pcs.: 2023-11-22 13 mm mushroom ear tip, hard version