FDA.reportPublic FDA data

CareMates

Primary DI
10715912207115
Brand
CareMates
Company
Shepard Medical Products, Inc.
Model
20711020
Device description
CareMates 20ct Earloop/Patient Masks
Published
2023-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10715912207115PrimaryGS10
00715912207118Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1071591220711510715912207115
00715912207118007159122071187159122071180715912207118

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
630-539-7790info@shepard-medical.com

Regulatory Flags#

DUNS number
609079769
Device count
20
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10087701431224Good Neighbor101871332023-01-06
10087701431231Good Neighbor101871312023-01-06
10087701431248Good Neighbor101871342023-01-06
10087701434423Good Neighbor102643902023-01-06
10096295122296Leader45598602023-01-06
10715912014133CareMates014130202023-01-06
10715912016137CareMates016130202023-01-06
10715912016335WorkMates016330902023-01-06
10715912053118CareMates053110202023-01-06
10715912053125CareMates053120202023-01-06
10715912053132CareMates053130202023-01-06
10715912053415UltiMates053410802023-01-06
10715912053422UltiMates053420802023-01-06
10715912053439UltiMates053430802023-01-06
10715912053446UltiMates053440802023-01-06
10715912054115CareMates054110202023-01-06
10715912054122CareMates054120202023-01-06
10715912054139CareMates054130202023-01-06
10715912056119CareMates056110202023-01-06
10715912056126CareMates056120202023-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810145950975NeuMask PinkMedgluv Inc.FXX2026-07-17
00850005229728NeuMask OrangeMedgluv Inc.FXX2026-07-17
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00810145952696NeuMask BlackMedgluv Inc.FXX2026-06-30
00850056441261Target Up&UpTARGET CORPORATIONFXX2026-06-25
00850056441254Target Up&UpTARGET CORPORATIONFXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03