Insert Earphone PIEP monaural

GUDID 04260223143564

Bio-Logic branded PIEP monaural (IP-05)

PATH medical GmbH

Evoked-potential audiometer

• Primary Device ID: 04260223143564
• NIH Device Record Key: f92bee96-9c42-493e-8e4c-7be5269a23b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insert Earphone PIEP monaural
• Version Model Number: 100867-BL
• 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	04260223143564 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-06-01

On-Brand Devices [Insert Earphone PIEP monaural]

• 04260223143564: Bio-Logic branded PIEP monaural (IP-05)
• 04260223143090: Monaural insert earphone IP-05M