FDA.reportPublic FDA data

GLOBAL HEALTHCARE

Primary DI
20872237000214
Brand
GLOBAL HEALTHCARE
Company
GHC HEALTHCARE, INC.
Model
04-EL
Device description
FACE MASK, EAR LOOP, BLUE, 3 PLY
Published
2017-02-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
40872237000218PackageGS16In Commercial Distribution
20872237000214PrimaryGS10
00872237000210Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
4087223700021840872237000218
2087223700021420872237000214
00872237000210008722370002108722370002100872237000210

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Regulatory Flags#

DUNS number
884718776
Device count
50
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00872237001804GLOBAL HEALTHCARE60-T022023-03-16
40872237001802GLOBAL HEALTHCARE60-T022023-03-16
00872237008568GLOBAL HEALTHCARE60-TN14012017-02-10
00872237001088GLOBAL HEALTHCARE63-45302017-02-10
00872237001095GLOBAL HEALTHCARE63-45312017-02-10
00872237001101GLOBAL HEALTHCARE63-45322017-02-10
00872237004256GLOBAL HEALTHCAREUB-LE6002016-09-12
00872237005192GLOBAL HEALTHCARE81-0012016-09-12
00872237005208GLOBAL HEALTHCARE81-0022016-09-12
00872237008674GLOBAL HEALTHCARE81-003A2016-09-12
00872237008681GLOBAL HEALTHCARE81-004A2016-09-12
00872237008698GLOBAL HEALTHCARE81-005A2016-09-12
00872237008711GLOBAL HEALTHCARE81-007A2016-09-12
00872237009114GLOBAL HEALTHCARE07-21M 2020-08-04
00872237009121GLOBAL HEALTHCARE07-21L2020-08-04
00872237009138GLOBAL HEALTHCARE07-21XL2020-08-04
00872237009145GLOBAL HEALTHCARE07-21XXL2020-08-04
00872237004263GLOBAL HEALTHCAREUB-PC2016-09-12
00872237004270GLOBAL HEALTHCAREUB-RC2016-09-12
00872237004751GLOBAL HEALTHCAREUB-P2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19