FDA.reportPublic FDA data

Medline

Primary DI
30197344019537
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON26595
Catalog number
NON26595
Device description
N95, POUCH, BLUE
Published
2024-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
30197344019537PackageGS16In Commercial Distribution
20197344019530PrimaryGS10
10197344019533Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019734401953730197344019537
2019734401953020197344019530
1019734401953310197344019533

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry. Avoid excessive heat - protect from freezing.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817169029649Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCMSH2026-03-05
00860014697302RiskWise SuppliesRiskWise Supplies LLCMSH2026-02-17
00860014697319RiskWise Supplies RiskWise Supplies LLCMSH2026-02-17
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
00850017658264Lighthouse Worldwide Solutions IncLighthouse Worldwide Solutions, Inc.MSH2025-02-11
00850056748070FORWARD Enforcement Group Medical BagINTEGRATED MEDCRAFT LLCMSH2024-10-04
10852212003693ProGearPRESTIGE AMERITECH, LTD.MSH2024-03-01
06946276000013Particulate RespiratorShanghai Gangkai Purifying Products Co., Ltd.MSH2024-02-23
00044585833301GERSONLOUIS M. GERSON CO.MSH2024-01-12
06924997807876Makrite Industries Inc.DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.MSH2023-09-28
06924997809061Makrite Industries Inc.DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.MSH2023-09-28
06924997819114Makrite Industries Inc.DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.MSH2023-09-28
10860008614671AtlanticMEDAtlantic Trading LLCMSH2023-09-08
16973875280741Makrite Industries Inc.Makrite Hubei Industrial Co., Ltd.MSH2023-07-21
16973875280758Makrite Industries Inc.Makrite Hubei Industrial Co., Ltd.MSH2023-07-21
16973875280765Makrite Industries Inc.Makrite Hubei Industrial Co., Ltd.MSH2023-07-21
06973875281017Makrite Industries Inc.Makrite Hubei Industrial Co., Ltd.MSH2023-07-14
06973875280072Makrite Industries Inc.Makrite Hubei Industrial Co., Ltd.MSH2023-07-14
06973875281000Makrite Industries Inc.Makrite Hubei Industrial Co., Ltd.MSH2023-07-06
06974669350223MDHCMDHC Life Technologies (Kunshan) Co., LTD.MSH2023-07-06
16973178959016Master& FrankDongguan Shin Yi Healthcare Products FactoryMSH2023-06-30
00686864059578MEDICOM SAFEMASKAMD Medicom IncMSH2023-05-25
00850017658127Lighthouse Worldwide Solutions IncLighthouse Worldwide Solutions, Inc.MSH2023-02-27
00715912017106CareMatesShepard Medical Products, Inc.MSH2023-01-06
00044585917308GERSONLOUIS M. GERSON CO.MSH2023-01-03
00810084939307WeCareJeg & Sons Inc.MSH2022-12-16