FDA.reportPublic FDA data

Curad

Primary DI
10193489079562
Brand
Curad
Company
MEDLINE INDUSTRIES, INC.
Model
CUR38325V1
Catalog number
CUR38325V1
Device description
MASK,FACE,PROCEDURE,EARLOOPS, 25 CT
Published
2022-12-01
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
10193489079562PackageGS112In Commercial Distribution
00193489079565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019348907956210193489079562
00193489079565001934890795651934890795650193489079565

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, non-antimicrobial, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and 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) and/or transparent face/eye visor. This is a single-use device.

Storage And Handling#

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

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
true
Expiration date on label
false
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