FDA.reportPublic FDA data

JMU

Primary DI
00840456201015
Brand
JMU
Company
JMU DENTAL, INC
Model
13001001
Device description
"Barrier Film, 4""x6"", Thickness 0.05mm, Plastic Core, 1200 Sheets/Roll, 1 Roll/Box, White"
Published
2025-07-15
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
FRKChair, Examination And Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRKChair, Examination And TreatmentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456201015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456201015008404562010158404562010150840456201015

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081258380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
08500190351415Maxi S4000 Exam Chair, Power Base/Recline, Arms, Art HR, WhiteBoyd Industries, Inc.FRK2025-12-26
00728564010005Versa Exam TableThe Brewer Company LLCFRK2025-11-10
00728564015000Blood Drawing ChairThe Brewer Company LLCFRK2025-11-10
00728564020103Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020301Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020400Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021100Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021308Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021407Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022107Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022305Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022404Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564050001Access Exam TableThe Brewer Company LLCFRK2025-11-10
00728564050018Access Exam TableThe Brewer Company LLCFRK2025-11-10
00840456201022JMUJMU DENTAL, INCFRK2025-07-15
00840456201039JMUJMU DENTAL, INCFRK2025-07-15
00840456201046JMUJMU DENTAL, INCFRK2025-07-15
00840456202906JMUJMU DENTAL, INCFRK2025-07-15
00840456202913JMUJMU DENTAL, INCFRK2025-07-15
00840456202920JMUJMU DENTAL, INCFRK2025-07-15
00840456202937JMUJMU DENTAL, INCFRK2025-07-15
00198506083952ELMED INCORPORATEDELMED INCORPORATEDFRK2025-07-11
06973134772133silverfoxSilverfox Corporation LimitedFRK2025-07-09
06973134774113silverfoxSilverfox Corporation LimitedFRK2025-07-09
D974BSI29111BritedentBright Supply, Inc.FRK2025-03-11
D974BSI29112BritedentBright Supply, Inc.FRK2025-03-11
00198506075179ELMED INCORPORATEDELMED INCORPORATEDFRK2025-02-17
00842180190122ELMEDELMED INCORPORATEDFRK2024-04-09
00842180147768ELMEDELMED INCORPORATEDFRK2024-03-06
06973134774052silverfoxSilverfox Corporation LimitedFRK2023-12-15