ALGO 5 011120

GUDID 05713315012198

ATA 5 V.2

Natus Medical Denmark ApS

Evoked-potential audiometer

• Primary Device ID: 05713315012198
• NIH Device Record Key: 1537fec9-cdd9-414a-87ec-5adda8bc43c4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGO 5
• Version Model Number: 011120
• Catalog Number: 011120
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315012198 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073665

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: 2025-12-10
• Device Publish Date: 2025-12-02

On-Brand Devices [ALGO 5]

• 05713315012204: A5 LASER PRINTER
• 05713315012198: ATA 5 V.2
• 05713315012181: PRINTER WITH DUALLOCK / PAPER
• 05713315012174: Preamp 5 Cable Assembly, A5
• 05713315012167: ALGO® 5 Patient Cable Assembly (PCA 5)