FDA.reportPublic FDA data

WeCare

Primary DI
00810084932094
Brand
WeCare
Company
Jeg & Sons Inc.
Model
Dark Gray - Adults
Catalog number
WMN100142
Device description
KN95 Masks 20-Pack
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QKRFace Mask Per Enforcement Policy For Face Masks And Respirators During The Declared Public Health Emergency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKRFace Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella EuaUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810084932094PrimaryGS10
00810084939314Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810084932094008100849320948100849320940810084932094
00810084939314008100849393148100849393140810084939314

GMDN Terms#

Term, Definition table
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 and small particles when considered necessary (e.g., viral epidemic). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Regulatory Flags#

DUNS number
789973646
Device count
20
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810084936887FifthPulse5 PackFMN1005252022-12-16
00810084936894FifthPulse10 PackFMN1005262022-12-16
00810084938355FifthPulse10 PackFMN1005262022-12-16
00810084936900FifthPulse10 PackFMN1005272022-12-16
00810084936917FifthPulse20 PackFMN1005282022-12-16
00810084938362FifthPulse20 PackFMN1005282022-12-16
00850026094305FifthPulseFP050-TS2021-07-01
00850026094312FifthPulseFP050-L2021-07-01
00850028714492FifthPulseFP100-TS2021-07-01
00850028714508FifthPulseFP100-L2021-07-01
00850026094299FifthPulseFP607-G2021-07-01
00850028714614FifthPulseFP607-GK2021-07-01
00683346554989WeCare3-Ply BlueWMN1000042022-12-16
00683346554996WeCare3-Ply BlueWMN1000052022-12-16
00810084932087WeCareNavy - AdultsWMN1001412022-12-16
00810084932810WeCareOcean Tones - AdultsWMN1001232022-12-16
00810084932827WeCareEarth Tones - AdultsWMN1001262022-12-16
00810084932834WeCareAssorted Tie Dye - AdultsWMN1001272022-12-16
00810084939307WeCareNavy - AdultsWMN1001412022-12-16
00810084939314WeCareDark Gray - AdultsWMN1001422022-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975089780010DISPOSABLE FACE MASKHubei Qifu Protective Products Co.,LtdQKR2025-12-23
00057475696009BIOS ProfessionalThermor LtdQKR2023-09-20
40841767107711Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-09-07
00841767107713Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-09-07
40841767107728Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-30
00841767107720Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-30
10841767106034Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106004Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106011Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106028Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
40841767106226Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106037Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106006Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106013Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106020Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
00841767106228Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-08-29
04007418891141Medical Face MaskHans Hepp GmbH & Co. KGQKR2023-07-28
04007418891158Medical Face MaskHans Hepp GmbH & Co. KGQKR2023-07-28
40841767107650Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-03-28
00841767107652Trinity Sterile, Inc.Trinity Sterile, Inc.QKR2023-03-28
06974424843502LEBOOLeboo Healthcare Products LimitedQKR2023-03-21
00810084939314WeCareJeg & Sons Inc.QKR2022-12-16
06973509180006TongdaXiantao Tongda Non-Woven Products Co., Ltd.QKR2022-12-02
088097834906243PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834906314PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834905253PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
088097834905324PLY SURGICAL MASKUNICO GLOBAL INCQKR2022-03-18
07506561200130INDALJIMTMIndaljim, S.A. de C.V.QKR2022-01-28
00816703025864MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13
00816703025871MedSource Face MaskMEDSOURCE INTERNATIONAL LLCQKR2021-05-13