FDA.reportPublic FDA data

E-A-RLINK™

Primary DI
00080529510136
Brand
E-A-RLINK™
Company
3M COMPANY
Model
420-2004
Catalog number
420-2004
Device description
3M(TM) E-A-RLINK(TM) 3A Foam Eartip adult size, yellow, with black tube 420-2004, 500/case
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETTCUSHION, EARPHONE (FOR AUDIOMETRIC TESTING)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETTCushion, Earphone (For Audiometric Testing)Ear, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10080529510133PackageGS110In Commercial Distribution
00080529510136PrimaryGS10
00051131273245Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1008052951013310080529510133
00080529510136000805295101360805295101360080529510136
00051131273245000511312732450511312732450051131273245

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric ear tipA 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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)733-45123Mhealthcarecompliance@mmm.com

Regulatory Flags#

DUNS number
078763316
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
007073877752543M™ Bair Hugger™30077300772026-05-15
007073877752613M™ Bair Hugger™31077310772026-05-15
007073877752853M™ Bair Hugger™53777537772026-05-15
007073877753083M™ Bair Hugger™55077550772026-05-15
007073877753153M™ Bair Hugger™55577555772026-05-15
007073878188833M™ Bair Hugger™54501545012026-05-15
007073878188903M™ Bair Hugger™55001550012026-05-15
007073878189063M™ Bair Hugger™55502555022026-05-15
007073878189133M™ Bair Hugger™58502585022026-05-15
007073878189203M™ Bair Hugger™63501635012026-05-15
007073878189373M™ Bair Hugger™57502575022026-05-15
007073878189443M™ Bair Hugger™45035450352026-05-15
007073878189513M™ Bair Hugger™45535455352026-05-15
007073878189683M™ Bair Hugger™55078550782026-05-15
007073878189753M™ Bair Hugger™55578555782026-05-15
106058610760643M™ Filtek™6555A3-S6555A3-S2026-05-08
106058610773823M™ Filtek™4867A14867A12026-05-08
106058610773993M™ Filtek™4867A24867A22026-05-08
106058610774053M™ Filtek™4867A34867A32026-05-08
106058610774123M™ Filtek™4867B14867B12026-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B43061000100GoCheck Audiometric Headphone AssemblyGobiquity, Inc.ETT2026-06-02
04260223146589Ear Tip ET-LT40G Pack/100 pcs.PATH medical GmbHETT2023-11-14
04260223146602Ear Tip ET-LT45G Pack/100 pcs.PATH medical GmbHETT2023-11-14
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