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

• 05713315012075 - OAE Eartips: 2025-12-30 OAE Pediatric Foam Tip (20x)
• 05713315012082 - OAE Eartips: 2025-12-30 OAE Adult Foam Tip (20)
• 05713315012099 - OAE Eartips: 2025-12-30 OAE TreeTip (20)
• 05713315012105 - OAE Eartips: 2025-12-30 OAE Preemie TreeTip (20)
• 05713315012112 - OAE Eartips: 2025-12-30 OAE Jumbo Foam Tip (100)
• 05713315012129 - OAE Eartips: 2025-12-30 OAE Pediatric Foam Tip (100)
• 05713315012136 - OAE Eartips: 2025-12-30 OAE Adult Foam Tip (100)
• 05713315012143 - OAE Eartips: 2025-12-30 OAE TreeTip (100)