FDA.report

Care One

Primary DI
10041520974829
Brand
Care One
Company
APOTHECARY PRODUCTS, LLC
Model
F405-605CO1
Device description
High Filtration Efficiency Face Mask
Published
2019-01-09
Public version status
Update
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
MSHRespirator, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
MSHRespirator, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10041520974829PackageGS14In Commercial Distribution
20025715036575PackageGS16In Commercial Distribution
00041520874825PrimaryGS10
04004152087489Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004152097482910041520974829
2002571503657520025715036575
00041520874825000415208748250415208748250041520874825
04004152087489040041520874894004152087489

GMDN Terms

TermDefinition
Public respirator, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). It is typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
9528901940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags

DUNS number
092312735
Device count
5
DM exempt
true
Premarket exempt
false
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
true
Sterilization required before use
false

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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

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