FDA.reportPublic FDA data

MEDLINE

Primary DI
00197344154336
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
NON25511
Catalog number
NON25511
Device description
SURGICAL N95 RESP, FISHEYE STYLE
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
10197344154333PackageGS112In Commercial Distribution
00197344154336PrimaryGS10
20197344154330Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019734415433310197344154333
00197344154336001973441543361973441543360197344154336
2019734415433020197344154330

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
30
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
10197344220588MEDLINEMSC608ASGVMSC608ASGV2026-11-03
10198459763977MEDLINEURO195714URO1957142026-09-15
10198459809224MEDLINEVASC2005VASC20052026-11-03
10198459814969MEDLINEVASC2008VASC20082026-11-03
10198459815508MEDLINEVASC1794CVASC1794C2026-11-03
10653160394471MEDLINEDYNDV2774ADYNDV2774A2026-11-04
20888277636757MEDLINEMDTZ1068516AWMDTZ1068516AW2026-11-03
20080196921277GeminiGEM2140GEM21402016-10-14
10197344148462MEDLINERTDCIHCMGRTDCIHCMG2026-10-30
10197344148479MEDLINERTDCIHCMNRTDCIHCMN2026-10-30
10197344148486MEDLINERTDCIHCMPRTDCIHCMP2026-10-30
10197344148493MEDLINERTDCIHCMRRTDCIHCMR2026-10-30
10197344148509MEDLINERTDCIHCMYRTDCIHCMY2026-10-30
10197344148516MEDLINERTDCIHCMZRTDCIHCMZ2026-10-30
10197344148523MEDLINERTDCINCMBRTDCINCMB2026-10-30
10197344148530MEDLINERTDCINCMGRTDCINCMG2026-10-30
10197344148547MEDLINERTDCINCMNRTDCINCMN2026-10-30
10197344148554MEDLINERTDCINCMPRTDCINCMP2026-10-30
10197344148561MEDLINERTDCINCMRRTDCINCMR2026-10-30
10197344148578MEDLINERTDCINCMYRTDCINCMY2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00086001469732RiskWise Health KitsRiskWise 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
06924997807876Makrite Industries Inc.DONGGUAN SURE_ON PLASTIC & FIBER PRODUCTS CO.,LTD.MSH2023-09-28