FDA.reportPublic FDA data

Apex

Primary DI
00076855000144
Brand
Apex
Company
Drive Devilbiss Healthcare
Model
00014
Device description
Silicone Ear Plugs (Small) - 6 Pair
Published
2023-01-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWDProtector, Hearing (Insert)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWDProtector, Hearing (Insert)UnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30076855000145PackageGS1144In Commercial Distribution
00076855000144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3007685500014530076855000145
00076855000144000768550001440768550001440076855000144

GMDN Terms#

Term, Definition table
TermDefinition
Earplugs, single-useA device, usually used as a pair, made of rubber or pliable plastic/silicone material intended to be inserted 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.

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
867673159
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10092237600105Roscoe MedicalEP4070WCD2016-10-18
90002360125501AccuReliefACRL-55002016-10-12
00009223761699Reliable MedicalEF2020BC2-TU2018-06-13
00009223761941EswallowESW-90502016-12-31
00023601005144CAREX HEALTH BRANDSFGA51400 00002022-12-20
00023601005151CAREX HEALTH BRANDSFGA51500 BLUE2022-12-20
00023601005168CAREX HEALTH BRANDSFGA51600 GRN2022-12-20
00023601005175CAREX HEALTH BRANDSFGA51700 BRNZ2022-12-20
00023601005182CAREX HEALTH BRANDSFGA51800 GRAY2022-12-20
00023601007117CAREX HEALTH BRANDSFGA71100 00002023-03-15
00023601007179CAREX HEALTH BRANDSFGA71700 00002023-03-15
00023601007186CAREX HEALTH BRANDSFGA71800 00002023-03-15
00023601007193CAREX HEALTH BRANDSFGA71900 00002023-03-15
00023601012210Carex Health BrandsFGA22100 00002022-12-09
00023601012227CAREX HEALTH BRANDSFGA22200 00002022-12-12
00023601012234CAREX HEALTH BRANDSFGA22300 00002022-12-12
00023601012302CAREX HEALTH BRANDSFGA23000 00002022-12-12
00023601012319CAREX HEALTH BRANDSFGA23177 00002022-12-12
00023601012333CAREX HEALTH BRANDSFGA23300 00002022-12-12
00023601013330CAREX HEALTH BRANDSFGA33300 00002022-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00311917079592WalgreensWALGREEN CO.EWD2026-02-19
10311917079599WalgreensWALGREEN CO.EWD2026-02-19
00033732000789Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732007122Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732007184Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732100786Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732107129Mack'sMcKeon Products, Inc.EWD2025-08-05
00033732107181Mack'sMcKeon Products, Inc.EWD2025-08-05
G599103B0Aqua Plus Bulk BlueJkr Laboratories, Inc.EWD2025-02-07
G599103R0Aqua Plus Bulk RedJkr Laboratories, Inc.EWD2025-02-07
10194484320758CondorGRAINGER INTERNATIONAL, INC.EWD2024-09-05
EDET033491aquaplus colormix yellow 8 x 50 ml DETAX GmbHEWD2024-08-28
EDET033501aquaplus colormix green8 x 50 ml DETAX GmbHEWD2024-08-28
EDET033541aquaplus colormix orange 8 x 50 ml DETAX GmbHEWD2024-08-28
EDET041661bioflex 40 blue 4x50mlDETAX GmbHEWD2024-08-28
EDET041671bioflex 40 rose 4x50mlDETAX GmbHEWD2024-08-28
EDET041681bioflex 40 red 4x50mlDETAX GmbHEWD2024-08-28
EDET041691bioflex 40 transparent 4x50mlDETAX GmbHEWD2024-08-28
10850015055727ULINE REUSABLE EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-25
10850015055734ULINE REUSABLE EARPLUGS - CORDEDULINE, INC.EWD2024-07-25
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDULINE, INC.EWD2024-07-25
10850015055741ULINE BULLET EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
10850015055758ULINE BULLET EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
10850015055765ULINE BELL EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
10850015055772ULINE BELL EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
30850015055523ULINE BULLET EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
30850015055530ULINE BULLET EARPLUGS - CORDEDULINE, INC.EWD2024-07-23
30850015055547ULINE BELL EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-23
30850015055554ULINE BELL EARPLUGS - CORDEDULINE, INC.EWD2024-07-23