Algo 3i 010724

GUDID 05713315012228

ATA cable (long)

Natus Medical Denmark ApS

Evoked-potential audiometer

• Primary Device ID: 05713315012228
• NIH Device Record Key: a338f812-54e2-465a-bcf5-a56392d44f4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Algo 3i
• Version Model Number: 010724
• Catalog Number: 010724
• Company DUNS: 306633756
• Company Name: Natus Medical Denmark ApS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315012228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030823

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [Algo 3i]

• 05713315012242: PCA Cable with Locking Connector
• 05713315012235: ATA cable (short)
• 05713315012228: ATA cable (long)
• 05713315012211: Preamp cable with EEG lead cable (short)
• 05713315011726: Preamp Cable with Locking Connector