FDA.reportPublic FDA data

PrimaPro

Primary DI
00850022371509
Brand
PrimaPro
Company
PRIMARY PRODUCTS COMPANY
Model
B183028EL
Device description
PrimaPro GentleWare ASTM Level 3 Face Mask, Blue, 4 Ply with Ear Loops, Latex Free, 50 Masks/Box, 10 Box/Case, 500 Masks/Case, Single Use
Published
2020-09-18
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
10850022371506PackageGS110In Commercial Distribution
00850022371509PrimaryGS10
20850022371503Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002237150610850022371506
00850022371509008500223715098500223715090850022371509
2085002237150320850022371503

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, non-antimicrobial, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). 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
089569581
Device count
50
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022371424PrimaPro611-452020-09-09
00850022371431PrimaPro612-452020-09-09
00850022371448PrimaPro613-452020-09-09
00850022371455PrimaPro614-452020-09-09
00850022371523PrimaPro421-452020-12-30
00850022371530PrimaPro422-452020-12-30
00850022371547PrimaPro423-452020-12-30
00850022371554PrimaPro424-452020-12-30
00850022371561PrimaPro610-45420-45N2026-04-28
00850022371578PrimaPro525-452025-02-12
00850022371585PrimaPro520-452025-02-12
00850022371622PrimaPro275-452025-02-12
10850022371575PrimaPro525-452025-02-12
10850022371582PrimaPro520-452025-02-12
10850022371629PrimaPro275-452025-02-12
00850022371301PrimaPro311-452020-09-09
00850022371318PrimaPro312-452020-09-09
00850022371325PrimaPro313-452020-09-09
00850022371332PrimaPro314-452020-09-09
00850022371479PrimaProW182028EL-BX2020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169039EssentialsHENRY SCHEIN, INC.FXX2023-07-05
10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040165260CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168483CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168490CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168582CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168612CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168629CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26