ALGO 040532

GUDID 05713315011979

Algo Sample pack

Natus Medical Denmark ApS

Evoked-potential audiometer

• Primary Device ID: 05713315011979
• NIH Device Record Key: ba6adf6f-c109-44f9-a38d-915ea73cfe95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGO
• Version Model Number: 040532
• Catalog Number: 040532
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	05713315011979 [Primary]

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: 2025-12-19
• Device Publish Date: 2025-12-11

Devices Manufactured by Natus Medical Denmark ApS

• 05713315012068 - Echo-Screen III: 2026-02-06 Natus branded OAE Probe Body Nozzle (5/PKG)
• 05713315012013 - Echo-Screen III: 2026-02-05 ES III PCA Cable, 4'
• 05713315012037 - Echo-Screen III: 2026-02-05 Echo-Screen III 4' ATA Cable, Tested
• 05713315012051 - Echo-Screen III: 2026-02-05 Echo-Screen III 4' OAE Cable, Tested, V.2
• 05713315011436 - ALGO Pro: 2026-02-02 Algo Pro Newborn Hearing Screener
• 05713315011443 - ALGO Pro: 2026-02-02 Algo Pro Docking Station
• 05713315011450 - ALGO Pro: 2026-02-02 Algo Pro ATA cable 36 "
• 05713315011467 - ALGO Pro: 2026-02-02 Algo Pro ATA Cable 72 "