FDA.report

CARE ONE

Primary DI
20023185000331
Brand
CARE ONE
Company
APOTHECARY PRODUCTS, LLC
Model
F406-906CO1
Device description
CARE ONE SILICONE 6 PR 6/144
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

Related Records

Contact Domains

Product Codes

CodeName
EWDProtector, Hearing (Insert)

Product Code Classifications

CodeDeviceSpecialtyClass
EWDProtector, Hearing (Insert)UnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10023185000679PackageGS124In Commercial Distribution
20023185000331PackageGS16In Commercial Distribution
00041520875532PrimaryGS10
40023185069066Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1002318500067910023185000679
2002318500033120023185000331
00041520875532000415208755320415208755320041520875532
4002318506906640023185069066

GMDN Terms

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

Contacts

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

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