FDA.reportPublic FDA data

Medline

Primary DI
40193489436984
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
NON27378
Catalog number
NON27378
Device description
MASK,FACE,BLUE,PROCEDURE,EARLOOP
Published
2021-02-11
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
FXXMask, surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40193489436984PackageGS14In Commercial Distribution
40193489436991PackageGS12In Commercial Distribution
10080196717996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4019348943698440193489436984
4019348943699140193489436991
1008019671799610080196717996

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
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
20686864061933MEDICOM ASSUREMASK VALIANTAMD Medicom IncFXX2026-03-17
20686864061940MEDICOM ASSUREMASK VALIANTAMD Medicom IncFXX2026-03-17
00810194402715AiraAIRA, LLCFXX2026-03-10
00810194402746AiraAIRA, LLCFXX2026-03-10
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
00068113110610EquateWAL-MART STORES, INC.FXX2026-02-25
10612479275932McKessonMCKESSON MEDICAL-SURGICAL INC.FXX2026-02-20
08809755250164KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
00810132808135House Brand DentistryFrontier Dental Supply IncFXX2026-02-10
30197344179750MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-29
10311917079629WalgreensWALGREEN CO.FXX2026-01-22
30197344153163MEDLINEMEDLINE INDUSTRIES, INC.FXX2026-01-21
00810194402678AiraAIRA, LLCFXX2026-01-16
00810194402692AiraAIRA, LLCFXX2026-01-16
00810194402708AiraAIRA, LLCFXX2026-01-16
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box BlackPRACTICON, INC.FXX2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box BluePRACTICON, INC.FXX2026-01-08
00850025515092BAYLAB USABaylab USA, LLCFXX2026-01-05
00810126504395Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504449Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504456Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504494Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504616Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126504623Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126505651Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00810126505668Essentials by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
00817169029724The Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCFXX2025-12-16
30197344149388MEDLINEMEDLINE INDUSTRIES, INC.FXX2025-12-05
10842942017466PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20
10842942017473PRIMED / CaracalpriMED Medical Products IncFXX2025-11-20