OAE Eartips

Basic Information

• Brand Name: OAE Eartips
• Primary DI: 05713315012129
• Version / Model: 203211
• Company Name: Natus Medical Denmark ApS
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-22
• Public Version: 2
• Public Version Date: 2026-01-08
• Public Version Status: Update
• Public Device Record Key: a0180d35-20a2-49d2-a8fb-4edac1092292

Device Description

OAE Pediatric Foam Tip (100)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETT	Cushion, Earphone (For Audiometric Testing)	Ear, Nose, Throat	874.1100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35747	Evoked-potential audiometer	An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage.	No	Active
62133	Audiometric ear tip	A luminal device intended to be connected to the distal end of an audiometric sound delivery tube and inserted into the ear canal, to allow test sounds to be delivered to the ear in isolation from background noise. It is designed to create a seal inside the ear canal whilst allowing the sound tube to pass through the lumen. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315012129	GS1