FDA.reportPublic FDA data

CARE ONE

Primary DI
20023185000324
Brand
CARE ONE
Company
APOTHECARY PRODUCTS, LLC
Model
C265CO1
Device description
CARE ONE KIDS PLUGS
Published
2020-08-31
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
10023185000662PackageGS16In Commercial Distribution
20023185000324PackageGS16In Commercial Distribution
00041520875556PrimaryGS10
40023185002650Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002318500066210023185000662
2002318500032420023185000324
00041520875556000415208755560415208755560041520875556
4002318500265040023185002650

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
6
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
10025715673582FLENTS673582016-09-06
10025715848157FLENTS848152016-09-06
10025715014408EZY DOSE71091BLAMT2022-08-01
10025715014439EZY DOSE71091GAMT2022-08-01
10025715014446EZY DOSE71091PAMT2022-08-01
10025715014590EZY DOSE68259BLAMT2022-08-01
10025715014606EZY DOSE68259GAMT2022-08-01
10025715014613EZY DOSE68259PAMT2022-08-01
10023185001775Flents Protechs703182020-08-12
10023185001805Flents Protechs703192020-08-12
10023185001829Flents Protechs703202020-08-12
10025715014248EZY DOSE67755BL2022-05-24
10025715014255EZY DOSE67755G2022-05-24
10025715014262EZY DOSE67755P2022-05-24
10025715014316EZY DOSE68255BL2022-05-24
10025715014330EZY DOSE68255G2022-05-24
10025715014361EZY DOSE68255O2022-05-24
10025715013968EZY DOSE67015BKAMT2022-03-07
10025715029860Flents690182021-11-12
10077602775275Remind n Time70408AMZ2021-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10311917079599WalgreensWALGREEN CO.EWD2026-02-19
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
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
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDULINE, INC.EWD2024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDULINE, INC.EWD2024-07-25
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
EDET024231aquaplus colormix red/blue 8 x 50 ml DETAX GmbHEWD2024-05-28
30850015055493ULINE BULLET EARPLUGS REFILLULINE, INC.EWD2024-05-13
00850015055713ULINE EARPLUGS IN A BUCKETULINE, INC.EWD2024-05-13
20057475561035BIOS LivingThermor LtdEWD2024-03-23
20057475561042BIOS LivingThermor LtdEWD2024-03-23
20057475561011BIOS LivingThermor LtdEWD2024-03-22
20057475561028BIOS LivingThermor LtdEWD2024-03-22
20057475561059BIOS LivingThermor LtdEWD2024-03-22
20057475561066BIOS LivingThermor LtdEWD2024-03-22
20057475561073BIOS LivingThermor LtdEWD2024-03-22
20057475561080BIOS LivingThermor LtdEWD2024-03-22