ALGO Pro 036243

GUDID 05713315011511

Algo Pro Cart

Natus Medical Denmark ApS

Evoked-potential audiometer

• Primary Device ID: 05713315011511
• NIH Device Record Key: bdd59e71-1177-4203-9025-a33eeb1736bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGO Pro
• Version Model Number: 036243
• Catalog Number: 036243
• 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: true
• Serial Number: false
• 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	05713315011511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233649

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: 2026-02-02
• Device Publish Date: 2026-01-23

On-Brand Devices [ALGO Pro]

• 05713315011511: Algo Pro Cart
• 05713315011504: Algo Pro Bassinet Hook
• 05713315011498: Algo Pro DC-DC Convertor
• 05713315011481: Algo Pro PCA cable 72"
• 05713315011474: Algo Pro PCA Cable 36"
• 05713315011467: Algo Pro ATA Cable 72 "
• 05713315011450: Algo Pro ATA cable 36 "
• 05713315011443: Algo Pro Docking Station
• 05713315011436: Algo Pro Newborn Hearing Screener