FDA.report

JMU

Primary DI
00840456214770
Brand
JMU
Company
JMU DENTAL, INC
Model
25407005
Device description
JMU Isolation Gowns, 30gsm PP, knitted cuff, Green, 120*140cm, 10pcs/bag, 100pcs(10bags)/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
FMEGown, Examination

Product Code Classifications

CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840456214770PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456214770008404562147708404562147700840456214770

GMDN Terms

TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

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
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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