FDA.reportPublic FDA data

Medline

Primary DI
10884389129814
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
BIOE3013A
Catalog number
BIOE3013A
Device description
BIOMASK,ANTIVIRAL, CONVEX, BLUE, LF
Published
2016-10-14
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
OUKSurgical mask with antimicrobial/antiviral agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUKSurgical Mask With Antimicrobial/Antiviral AgentGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884389129818PackageGS125In Commercial Distribution
40884389129815PackageGS1200In Commercial Distribution
10884389129814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088438912981830884389129818
4088438912981540884389129815
1088438912981410884389129814

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical respirator, antimicrobialA 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 and small particles during medical, surgical, dental, and isolation procedures; it includes an antimicrobial/antiviral agent to destroy specified pathogens under specified contact conditions. 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.

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14
10653160393894MEDLINEEBSI1883EBSI18832026-10-15
10653160394310MEDLINEEBSI1365BEBSI1365B2026-10-15
10653160394327MEDLINEDYNDV2345BDYNDV2345B2026-10-15
10653160394334MEDLINEDYNDV2720ADYNDV2720A2026-10-15
10653160394426MEDLINEEBSI1339CEBSI1339C2026-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
40852212003717ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-08-05
50852212003714ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-08-05
10852212003716ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-01-13
30852212003710ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2025-01-13
00852212003719ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2024-10-21
80852212003715ProGear/OxafencePRESTIGE AMERITECH, LTD.OUK2024-10-21
00840039200640RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-08-10
00888277359867CuradMEDLINE INDUSTRIES, INC.OUK2021-04-15
40888277359865CuradMEDLINE INDUSTRIES, INC.OUK2021-04-15
00860006561826Cufitec Surgical MaskNBC MESHTEC INC.OUK2021-03-31
00888277359850MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OUK2021-03-16
00840039200626RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-02-25
00840039200565RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-02-25
00840039200558RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-22
00840039200015RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-13
00840039200527RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-13
00840039200213RespoKareINNONIX TECHNOLOGIES LIMITEDOUK2021-01-13
00708820228818Meijer MEIJER, INC.OUK2018-12-28
10884389148020MedlineMEDLINE INDUSTRIES, INC.OUK2016-10-14
30884389129818MedlineMEDLINE INDUSTRIES, INC.OUK2016-10-14