Flexicoupler 011445

GUDID 05713315011702

Flexicoupler Disposable Earphones w/Jelly Tab sensors

Natus Medical Denmark ApS

Evoked-potential audiometer

• Primary Device ID: 05713315011702
• NIH Device Record Key: 8121de0a-d304-4aef-99ab-e8d02d59de54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexicoupler
• Version Model Number: 011445
• Catalog Number: 011445
• 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	05713315011702 [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: 2025-12-19
• Device Publish Date: 2025-12-11

On-Brand Devices [Flexicoupler]

• 05713315011993: Flexicoupler Valu-Pak 288 sets of supplies
• 05713315011986: Flexicoupler Algo Pak - 36 sets of supplies
• 05713315011702: Flexicoupler Disposable Earphones w/Jelly Tab sensors