INFANT E-A-RTIP

Basic Information

• Brand Name: INFANT E-A-RTIP
• Primary DI: 00080529510105
• Version / Model: 420-2094
• Catalog Number: 420-2094
• Company Name: 3M COMPANY
• Labeler DUNS: 078763316
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: f5cfd354-ebfb-45dd-b06a-ae424fac9b57

Device Description

3M(TM) Infant Eartip 3.5mm 420-2094-5, 10 pair/case

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
62133	Audiometric ear tip	A non-sterile 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	00080529510105	GS1
Unit of Use	00051131273313	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]