FDA.reportPublic FDA data

FLENTS

Primary DI
00023185006032
Brand
FLENTS
Company
APOTHECARY PRODUCTS, LLC
Model
F405-603
Device description
MAXI-MASK ULTRA 95
Published
2016-09-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
10023185006039PackageGS16In Commercial Distribution
20023185006036PackageGS14In Commercial Distribution
00023185006032PrimaryGS10
40023185006030Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1002318500603910023185006039
2002318500603620023185006036
00023185006032000231850060320231850060320023185006032
4002318500603040023185006030

GMDN Terms#

Term, Definition table
TermDefinition
Public respirator, single-useA form-shaped filtering mask designed to be placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles (e.g., blood, body fluids, and airborne particulate materials) and small particles (e.g., bacteria and viruses) when considered necessary (e.g., viral epidemic). 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

Contacts#

Phone, Email table
PhoneEmail
9528901940UDI@APOTHECARYPRODUCTS.COM

Regulatory Flags#

DUNS number
092312735
Device count
2
DM exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00031046605065Ezy Dose Self-Care69797/697982021-03-26
00079573104361Acu-Life (HE)400436/400436A2020-09-10
00023185056051FLENTSF405-6052019-01-09
00025715010441FLENTSF405-6042016-09-06
00041520874825Care OneF405-605CO12019-01-09
00025715673585FLENTS673582016-09-06
00025715848150FLENTS848152016-09-06
10025715673582FLENTS673582016-09-06
10025715848157FLENTS848152016-09-06
00023185056204FLENTSF405-6202016-09-06
00025715669502Diabetic Specialty Solutions66949/66949AZ2020-09-10
00025715690025FLENTS654002016-09-06
00840986020131CDCF405-620CD2017-03-06
00681131161756Walmart69002WM2017-01-20
00025715014401EZY DOSE71091BLAMT2022-08-01
00025715014432EZY DOSE71091GAMT2022-08-01
00025715014449EZY DOSE71091PAMT2022-08-01
00025715014593EZY DOSE68259BLAMT2022-08-01
00025715014609EZY DOSE68259GAMT2022-08-01
00025715014616EZY DOSE68259PAMT2022-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086001469732RiskWise Health KitsRiskWise Supplies LLCMSH2026-05-18
00860014697333RiskWise Health Kits RiskWise Supplies LLCMSH2026-05-18
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