FDA.reportPublic FDA data

Uline Earmuff - Black

Primary DI
10851253007547
Brand
Uline Earmuff - Black
Company
ULINE, INC.
Model
S-20706BL
Catalog number
S-20706BL
Published
2019-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EWEProtector, Hearing (Circumaural)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWEProtector, Hearing (Circumaural)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30851253007541PackageGS120In Commercial Distribution
10851253007547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3085125300754130851253007541
1085125300754710851253007547

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

Regulatory Flags#

DUNS number
039612668
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850015055826Trauma KitH-99542026-04-06
10851253007691Uline Burn Kit - Single UseH-4172H-41722019-01-18
10850015055789ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
10850015055796ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
10850015055802ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28
10850015055819ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XLS-12549X2025-04-28
30850015055561ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
30850015055578ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
30850015055585ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28
30850015055592ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XLS-12549X2025-04-28
10850015055307Uline 25 Person First Aid Kit - SUBH-1293-S12022-01-14
10850015055314Uline 50 Person First Aid Kit - SUBH-1294-S12022-01-14
10850015055727ULINE REUSABLE EARPLUGS - UNCORDEDS-198732024-07-25
10850015055734ULINE REUSABLE EARPLUGS - CORDEDS-198742024-07-25
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDS-198732024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDS-198742024-07-25
10850015055741ULINE BULLET EARPLUGS - UNCORDEDS-179022024-07-23
10850015055758ULINE BULLET EARPLUGS - CORDEDS-179032024-07-23
10850015055765ULINE BELL EARPLUGS - UNCORDEDS-221402024-07-23
10850015055772ULINE BELL EARPLUGS - CORDEDS-221412024-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628725095318Micro MinimuffsCHS USA Inc.EWE2026-01-07
50628725095313Micro MinimuffsCHS USA Inc.EWE2026-01-07
00628725095295MiniMuffsCanadian Hospital Specialties LimitedEWE2025-04-11
50628725095290MiniMuffsCanadian Hospital Specialties LimitedEWE2025-04-11
10194484320734CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
10194484320741CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
20194484320731CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
20194484320748CondorGRAINGER INTERNATIONAL, INC.EWE2024-09-20
00860008980700DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980717DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980724DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980731DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980748DREAMIES T-MNEATCAP MEDICAL LLCEWE2022-12-08
00860008980755DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980762DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980779DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980786DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00860008980793DREAMIESNEATCAP MEDICAL LLCEWE2022-12-08
00033552000242Howard Leight by HoneywellSPERIAN HEARING PROTECTION, LLCEWE2020-09-22
00033552022053Howard Leight by HoneywellSPERIAN HEARING PROTECTION, LLCEWE2020-09-21
00033552015260 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552015307 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552019022Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552022312Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
00033552025221Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
07312550119945Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
10033552015267 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
10033552015304 Howard Leight SPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552019026Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31
20033552022316Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31