Madsen Zodiac 8-35-10001

GUDID 05713315009907

1096 Zodiac Quick Check Probe Gen 2 Kit

Natus Medical Denmark ApS

Impedance audiometer

• Primary Device ID: 05713315009907
• NIH Device Record Key: 2190a75b-cc1d-4955-b2ac-55e177f117f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Madsen Zodiac
• Version Model Number: 8-35-10001
• Catalog Number: 8-35-10001
• Company DUNS: 306633756
• Company Name: Natus Medical Denmark ApS
• 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	05713315009907 [Primary]

FDA Product Code

• ETY: Tester, Auditory Impedance

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: 2025-04-18
• Device Publish Date: 2022-12-15

On-Brand Devices [Madsen Zodiac]

• 05713315009914: 1096 Zodiac Diagnostic Probe Gen 2 Kit
• 05713315009907: 1096 Zodiac Quick Check Probe Gen 2 Kit
• 05713315009396: 1096 Zodiac Quick Check Probe Gen 2
• 05713315009389: 1096 Zodiac Diagnostic Probe Gen 2