FDA.reportPublic FDA data

DF365N95HC Respirator

Primary DI
00883940410425
Brand
DF365N95HC Respirator
Company
North Safety de Mexicali, S. de R. L. de C.V.
Model
DF365N95HC
Device description
Honeywell DF365N95HC Surgical N95 Respirator Mask w/ Nose clip
Published
2022-08-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MSHRespirator, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00883940410425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00883940410425008839404104258839404104250883940410425

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 typically made of multiple layers of non-woven polymers to produce a soft, flexible mask that will create an airtight seal against the user’s face and typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
812503712
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821812046778Honeywell Safety Products USA, Inc.013087-1725A2021-02-08
00821812020976Honeywell Safety Products USA, Inc.018503-42192020-09-26
00821812021270Honeywell Safety Products USA, Inc.010101-4354L2020-09-26
00821812024462Honeywell Safety Products USA, Inc.011798-14942020-09-24
00821812024523Honeywell Safety Products USA, Inc.018504-42222020-09-26
00821812025032Honeywell Safety Products USA, Inc.019700-0001L2020-09-26
00821812025193Honeywell Safety Products USA, Inc.019709-0005L2020-09-26
00821812025216Honeywell Safety Products USA, Inc.019710-0006L2020-09-26
00821812025278Honeywell Safety Products USA, Inc.019713-0007L2020-09-26
00821812025315Honeywell Safety Products USA, Inc.019715-0008L2020-09-26
00821812030111Honeywell Safety Products USA, Inc.019746-0032L2020-09-26
00821812030289Honeywell Safety Products USA, Inc.019727-0014L2020-09-26
00821812030388Honeywell Safety Products USA, Inc.019741-0028L2020-09-24
00821812033785Honeywell Safety Products USA, Inc.010998-44072020-09-26
00821812040714Honeywell Safety Products USA, Inc.010742-32362020-09-24
00821812040752Honeywell Safety Products USA, Inc.010875-03492020-09-26
00821812040790Honeywell Safety Products USA, Inc.011007-43302020-09-26
00821812040813Honeywell Safety Products USA, Inc.011008-43312020-09-26
00821812042237Honeywell Safety Prodycts USA, Inc.010019-43202020-09-26
00821812400921Honeywell Safety Products USA, Inc.019700-4500F2020-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086001469732RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
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10326053123457Regard™Resource Optimization & Innovation, L.L.C.MSH2026-03-18
00817169029649Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMSH2026-03-05
00860014697302RiskWise SuppliesRiskWise Supplies LLCMSH2026-02-17
00860014697319RiskWise Supplies RiskWise Supplies LLCMSH2026-02-17
20680651492993HalyardO&M HALYARD, INC.MSH2025-09-30
20680651493006HalyardO&M HALYARD, INC.MSH2025-09-30
00639890596333RadnorLOUIS M. GERSON CO.MSH2025-04-14
00764423027777FastlineLOUIS M. GERSON CO.MSH2025-04-14
00850019086157Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096427MedavaLOUIS M. GERSON CO.MSH2025-04-14
00044585817301FastlineLOUIS M. GERSON CO.MSH2025-04-14
10850019086154Altor SafetyLOUIS M. GERSON CO.MSH2025-04-14
00850052096434MedavaLOUIS M. GERSON CO.MSH2025-04-14
00781311086104SAS Safety / GersonBunzl USA Holdings LLCMSH2025-04-04
10016659570150All Pro Bunzl USA Holdings LLCMSH2025-04-04
00850017658288SHIELDLWS HEALTH & SAFETY LLCMSH2025-02-11
00850017658264Lighthouse Worldwide Solutions IncLighthouse Worldwide Solutions, Inc.MSH2025-02-11
00850056748070FORWARD Enforcement Group Medical BagINTEGRATED MEDCRAFT LLCMSH2024-10-04
00628678429024VitacoreVitacore Industries IncMSH2024-09-05
00628678429031VitacoreVitacore Industries IncMSH2024-09-05
20197344019530MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
30197344019537MedlineMEDLINE INDUSTRIES, INC.MSH2024-03-27
00852212003696ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
10852212003693ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
16946276000010Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
06946276000013Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
00044585333016GERSONLOUIS M. GERSON CO.MSH2024-01-12
00044585833301GERSONLOUIS M. GERSON CO.MSH2024-01-12