FDA.report

JMU

Primary DI
00840456214237
Brand
JMU
Company
JMU DENTAL, INC
Model
13022001
Device description
JMU Keyboard Sleeves 22"x13.78"x2c (560mm×350mmx2c), 250pcs/Box,10Boxes/Case
Published
2025-07-15
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
true

Related Records

Product Codes

CodeName
PEMDental Barriers And Sleeves

Product Code Classifications

CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840456214237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456214237008404562142378404562142370840456214237

GMDN Terms

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

Regulatory Flags

DUNS number
081258380
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840456218686JMU229110052026-03-11
00840456218693JMU229110062026-03-11
00840456218709JMU229080322026-03-09
00840456218716JMU229080332026-03-09
00840456218723JMU229080342026-03-09
00840456218730JMU229080352026-03-09
00840456218747JMU229080362026-03-09
00840456218754JMU229080372026-03-09
00840456218761JMU229080382026-03-09
00840456218778JMU229080392026-03-09
00840456219416JMU510060012026-03-09
00840456219423JMU510060022026-03-09
00840456219430JMU510060122026-03-09
00840456219447JMU510060032026-03-09
00840456219454JMU510060142026-03-09
00840456219461JMU510060152026-03-09
00840456218303JMU241050012026-01-20
00840456218174JMU241190012026-01-09
00840456218181JMU241190022026-01-09
00840456217009JMU251010132025-12-31

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