FDA.reportPublic FDA data

PREMIER VALUE

Primary DI
00840986015854
Brand
PREMIER VALUE
Company
PHARMACY VALUE ALLIANCE, LLC
Model
F408-150CD
Device description
PVA 150 QUIET!PLEASE 10PR EAR PLUGS
Published
2020-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
10840986015851PackageGS112In Commercial Distribution
20840986015858PackageGS16In Commercial Distribution
00840986015854PrimaryGS10
40840986015852Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084098601585110840986015851
2084098601585820840986015858
00840986015854008409860158548409860158540840986015854
4084098601585240840986015852

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
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
089138159
Device count
10
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840986021558Premier Value84098602155840986021552022-06-21
00840986036637Premier Value84098603663840986036632022-06-21
00840986016639Premier Value One Step Pregnancy Test2016-08-30
00840986016646Premier Value One Step Pregnancy Test2016-08-30
00840986021091Premier Value Early Result Pregnancy Test2016-08-30
00840986036996Premier ValueOne Step Pregnancy Test2020-09-21
00840986037009Premier ValueOne Step Pregnancy Test2020-09-21
00840986037108Premier ValueAdvanced One-Step Pregnancy Test2020-11-11
00840986034992Premier Value AutoletAT 0270CDC2023-02-03
00761059272281Premier Value AutoletAT 0270CDC2023-02-03
00840986016684Premier Value Unilet LancetsAT 0575CDC2023-01-06
00840986032837Premier Value Unilet LancetsAT 0585CDC2023-01-06
10840986037105Premier ValueAdvanced One-Step Pregnancy Test2020-11-11
10840986021555Premier Value84098602155840986021552022-06-21
10840986036634Premier Value84098603663840986036632022-06-21
00040986026847Premier Value TamponsBPVGR202016-09-20
00840986016196Premier Value TamponsBPVAR402016-09-20
00840986016202Premier Value TamponsBPVAS402016-09-20
00840986016219Premier Value TamponsBPVAP402016-09-20
00840986026850Premier Value TamponsBPVGS182016-09-20

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