FDA.reportPublic FDA data

Howard Leight by Honeywell

Primary DI
00033552000242
Brand
Howard Leight by Honeywell
Company
SPERIAN HEARING PROTECTION, LLC
Model
AIRSOFT
Catalog number
AS-1
Device description
AirSoft Multiple-Use Earplug
Published
2020-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00033552000242PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00033552000242000335520002420335520002420033552000242

GMDN Terms#

Term, Definition table
TermDefinition
Earplugs, single-useA device usually used as a pair made of rubber or pliable plastic/silicone material for insertion into the outer ear canal for protection against excessive noise levels or water entering the ears when swimming/bathing. This device may be premoulded (preformed) or mouldable. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014982953
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00033552003717Howard LeightMAXMAX-1-D2020-07-31
00033552011521Howard LeightMATRIX MTX-1-OR2020-07-31
00033552013532Howard LeightMatrixMTX-1-OR-D2020-07-31
00033552015215Howard Leight by HoneywellAirSoftR-015212020-09-11
00033552016847Howard Leight by HoneywellAquaSealR-016842020-09-11
00033552022374Howard Leight by HoneywellTRUSTFIT PODR-022372020-09-11
00033552022053Howard Leight by HoneywellTRUSTFIT TRUSTFITPOD-12020-09-21
00033552022367Howard Leight by HoneywellTRUSTFIT R-022362020-09-11
10033552014345Howard LeightLeight SourceMAX-LS4E2020-08-14
00033552011101Howard LeightSuper LeightR-011102020-07-31
00033552011804Howard Leight by HoneywellSuper LeightR-011802020-07-31
00033552015178Howard LeightLeight PlugsR-015172020-07-31
00033552015185Howard LeightLeight PlugsR-015182020-07-31
00033552016694Howard Leight by HoneywellSuper LeightR-016692020-07-31
00033552016779Howard Leight by HoneywellSuper Leight R-016772020-07-31
00033552016809Leight SleepersHoward LeightR-016802020-07-31
00033552016816Howard LeightLeight SleepersR-016812020-07-31
00033552016823Howard LeightMulti LeightR-016822020-07-31
00033552017578Howard Leight by HoneywellSuper LeightR-017572020-07-31
00033552017769Howard LeightMAX USAR-017762020-07-31

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
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
20033552025225Howard LeightSPERIAN HEARING PROTECTION, LLCEWE2020-07-31