Echo-Screen III 012625

GUDID 05713315012051

Echo-Screen III 4' OAE Cable, Tested, V.2

Natus Medical Denmark ApS

Evoked-potential audiometer

• Primary Device ID: 05713315012051
• NIH Device Record Key: 0ff85a40-cd30-4635-ac23-0773aa843a98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Echo-Screen III
• Version Model Number: 012625
• Catalog Number: 012625
• 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	05713315012051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141446

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: 2026-02-05
• Device Publish Date: 2026-01-28

On-Brand Devices [Echo-Screen III]

• 05713315012051: Echo-Screen III 4' OAE Cable, Tested, V.2
• 05713315012037: Echo-Screen III 4' ATA Cable, Tested
• 05713315012013: ES III PCA Cable, 4'
• 05713315012068: Natus branded OAE Probe Body Nozzle (5/PKG)