FDA.reportPublic FDA data

FLENTS PROTECHS

Primary DI
20025715035622
Brand
FLENTS PROTECHS
Company
APOTHECARY PRODUCTS, LLC
Model
68052
Device description
PROTECHS SPORT EAR PLUGS 8 PR 6/72
Published
2020-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10025715040704PackageGS112In Commercial Distribution
20025715035622PackageGS16In Commercial Distribution
00025715680521PrimaryGS10
40025715680529Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002571504070410025715040704
2002571503562220025715035622
00025715680521000257156805210257156805210025715680521
4002571568052940025715680529

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

Contacts#

Phone, Email table
PhoneEmail
952-890-1940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
092312735
Device count
8
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00031046605065Ezy Dose Self-Care69797/697982021-03-26
00079573104361Acu-Life (HE)400436/400436A2020-09-10
00023185056051FLENTSF405-6052019-01-09
00025715010441FLENTSF405-6042016-09-06
00041520874825Care OneF405-605CO12019-01-09
00023185006032FLENTSF405-6032016-09-06
00025715673585FLENTS673582016-09-06
00025715848150FLENTS848152016-09-06
10025715673582FLENTS673582016-09-06
10025715848157FLENTS848152016-09-06
00023185056204FLENTSF405-6202016-09-06
00025715669502Diabetic Specialty Solutions66949/66949AZ2020-09-10
00025715690025FLENTS654002016-09-06
00840986020131CDCF405-620CD2017-03-06
00681131161756Walmart69002WM2017-01-20
00025715014401EZY DOSE71091BLAMT2022-08-01
00025715014432EZY DOSE71091GAMT2022-08-01
00025715014449EZY DOSE71091PAMT2022-08-01
00025715014593EZY DOSE68259BLAMT2022-08-01
00025715014609EZY DOSE68259GAMT2022-08-01

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