Maico DE

GUDID 04260176121169

MAICO Diagnostics GmbH

Otoacoustic emission system, line-powered

• Primary Device ID: 04260176121169
• NIH Device Record Key: ec558646-859a-421b-936b-cd62c942e348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maico DE
• Version Model Number: easyScreen
• Company DUNS: 344863550
• Company Name: MAICO Diagnostics 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260176121169 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171506

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: 4
• Public Version Date: 2019-03-08
• Device Publish Date: 2018-01-30

On-Brand Devices [Maico DE]

• 04260176121169: easyScreen
• 04260176121046: touchTymp