Infant E-A-Rtip

3M(TM) Infant Eartip 4.0mm 420-2095-5, 10 pair/case

Registry build 21.09.26
1manufacturer
2catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code ETT
Manufacturer City Province Registered as Device types
Guangdong Kelihuan Biotechnology Co., Ltd. Huizhou Guangdong Manufacturer 5

Record

Regulatory record for Infant E-A-Rtip
Listed by 3M Company, United States
FDA product code ETT
Device type Cushion, Earphone (For Audiometric Testing)
Device class Class 1
Regulation 21 CFR 874.1100
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2016-09-24
Record revised 2025-06-30 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for Infant E-A-Rtip
Catalogue number Size Per pack Status
420-2095 20 In distribution
420-2094 20 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Grason & Associates, LLC Grason & Associates, LLC 144
Sanibel Supply Interacoustics A/S 56
OAE Eartips Natus Medical Denmark ApS 9
E-A-Rlink™ 3M Company 8
Sanibel Supply A/S Interacoustics A/S 5
Maico Interacoustics A/S 3
GoCheck Audiometric Headphone Assembly Gobiquity, Inc. 2
Amplivox Interacoustics A/S 2
Etymotic Etymotic Research, Inc. 2
Foam Eartip 3C (Jumbo) Natus Manufacturing Limited 1
Interacoustics Interacoustics A/S 1
Foam Eartip, 3B (Small) Natus Manufacturing Limited 1

Showing 12 of 13. All products under Cushion, Earphone (For Audiometric Testing)

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer