FDA.reportPublic FDA data

JMU

Primary DI
00840456223932
Brand
JMU
Company
JMU DENTAL, INC
Model
35354013
Device description
JMU GD-2514 Retainer Box (79*78*29mm), Light blue+Pink each assorted per pack, sold by pack, 1pc/bag, 2pcs/pack
Published
2026-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JERCleaner, Denture, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JERCleaner, Denture, MechanicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456223932PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456223932008404562239328404562239320840456223932

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleaning containerA non-powered receptacle intended to be used to clean/rinse a denture or similar dental prosthesis (e.g., a bridge). It is in the form of a container intended to hold the denture, typically with a denture cleansing solution, which may be manually agitated. This is a reusable device.

Regulatory Flags#

DUNS number
081258380
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456201336JMU353540242026-08-18
00840456201343JMU353540252026-08-18
00840456201350JMU353540262026-08-18
00840456201367JMU353540272026-08-18
00840456201374JMU353540282026-08-18
00840456201381JMU353540292026-08-18
00840456201398JMU353540302026-08-18
00840456201404JMU353540312026-08-18
00840456201411JMU353540322026-08-18
00840456203163JMU170090042026-08-18
00840456207123JMU170090012026-08-18
00840456207130JMU170090022026-08-18
00840456216477JMU353540402026-08-18
00840456216484JMU353540392026-08-18
00840456216491JMU353540382026-08-18
00840456223628JMU170090032026-08-18
00840456223635JMU190010012026-08-18
00840456223642JMU190010022026-08-18
00840456223659JMU301020012026-08-18
00840456223789JMU350100042026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201336JMUJMU DENTAL, INCJER2026-08-18
00840456201343JMUJMU DENTAL, INCJER2026-08-18
00840456201350JMUJMU DENTAL, INCJER2026-08-18
00840456201367JMUJMU DENTAL, INCJER2026-08-18
00840456201374JMUJMU DENTAL, INCJER2026-08-18
00840456201381JMUJMU DENTAL, INCJER2026-08-18
00840456201398JMUJMU DENTAL, INCJER2026-08-18
00840456201404JMUJMU DENTAL, INCJER2026-08-18
00840456201411JMUJMU DENTAL, INCJER2026-08-18
00840456216477JMUJMU DENTAL, INCJER2026-08-18
00840456216484JMUJMU DENTAL, INCJER2026-08-18
00840456216491JMUJMU DENTAL, INCJER2026-08-18
00840456223819JMUJMU DENTAL, INCJER2026-08-18
00840456223826JMUJMU DENTAL, INCJER2026-08-18
00840456223833JMUJMU DENTAL, INCJER2026-08-18
00840456223840JMUJMU DENTAL, INCJER2026-08-18
00840456223857JMUJMU DENTAL, INCJER2026-08-18
00840456223864JMUJMU DENTAL, INCJER2026-08-18
00840456223871JMUJMU DENTAL, INCJER2026-08-18
00840456223888JMUJMU DENTAL, INCJER2026-08-18
00840456223895JMUJMU DENTAL, INCJER2026-08-18
00840456223901JMUJMU DENTAL, INCJER2026-08-18
00840456223918JMUJMU DENTAL, INCJER2026-08-18
00840456223925JMUJMU DENTAL, INCJER2026-08-18
00840456223949JMUJMU DENTAL, INCJER2026-08-18
00840456223956JMUJMU DENTAL, INCJER2026-08-18
00840456223963JMUJMU DENTAL, INCJER2026-08-18
00840456223970JMUJMU DENTAL, INCJER2026-08-18
00840456223987JMUJMU DENTAL, INCJER2026-08-18
00840456223994JMUJMU DENTAL, INCJER2026-08-18