JMU

Primary DI
D930240070040
Brand
JMU
Company
JMU DENTAL, INC
Model
24007004
Device description
ASTM Level 3 Four-Layer Medical Masks, Adult Size (17.5cmx9.5cm), 4 Assorted Patterned, 50pcs/box,40boxes/case
Published
2024-05-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220597000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220597000Disposable Surgical Face Mask (FM-34EE,FM-44EE)Qingdao Bestex Rubber & Plastic Products Co., Ltd.2022-05-26FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D930240070040PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
081258380
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456201756JMU481010012026-05-27
00840456201763JMU481010022026-05-27
00840456201770JMU481010032026-05-27
00840456201787JMU481010042026-05-27
00840456201794JMU481010052026-05-27
00840456221020JMU481010062026-05-27
00840456222423JMU361060082026-05-19
00840456222430JMU361060092026-05-19
00840456222447JMU361060102026-05-19
00840456222454JMU361060112026-05-19
00840456222461JMU361060122026-05-19
00840456222478JMU361060132026-05-19
00840456221532JMU387020762026-05-11
00840456221549JMU387020772026-05-11
00840456221556JMU387020782026-05-11
00840456221563JMU387020792026-05-11
00840456221570JMU387020802026-05-11
00840456221587JMU387020812026-05-11
00840456221594JMU387020822026-05-11
00840456221600JMU387020832026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10195327560522Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FXX2023-12-21
10097604537022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10097604538128Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2023-12-11
10304040169022EssentialsHENRY SCHEIN, INC.FXX2023-07-05
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10304040169046CriterionHENRY SCHEIN, INC.FXX2023-07-05
10304040165253CriterionHENRY SCHEIN, INC.FXX2023-06-26
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10304040168643CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168650CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168926CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168933CriterionHENRY SCHEIN, INC.FXX2023-06-26
10304040168940CriterionHENRY SCHEIN, INC.FXX2023-06-26
10087701434423Good NeighborShepard Medical Products, Inc.FXX2023-01-06
10096295122296LeaderShepard Medical Products, Inc.FXX2023-01-06
10096295137382LeaderShepard Medical Products, Inc.FXX2023-01-06