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
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
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03