FDA.report

JMU

Primary DI
00840456214923
Brand
JMU
Company
JMU DENTAL, INC
Model
20611004
Device description
JMU Cotton-Tipped Applicators, 3" length, paper-plastic wrapped, sterile,2pcs/pouch, 100 pouches/box
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
true
Single use
true

Related Records

Product Codes

CodeName
KXGApplicator, Absorbent Tipped, Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
KXGApplicator, Absorbent Tipped, SterileGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840456214923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456214923008404562149238404562149230840456214923

GMDN Terms

TermDefinition
General-purpose absorbent tip applicator/swab, single-useA hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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00840456218693JMU229110062026-03-11
00840456218709JMU229080322026-03-09
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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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