FDA.reportPublic FDA data

JMU

Primary DI
00840456209288
Brand
JMU
Company
JMU DENTAL, INC
Model
25406011
Device description
Plus SMS Lab Coat with 3 pockets, Knee Length, 40g SMS, Dark Blue, Medium 112x120cm, 1pc/transparent OPP bag, 50pcs/case
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
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456209288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456209288008404562092888404562092880840456209288

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
081258380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456200186JMU101070072026-07-06
00840456201435JMU130100122026-07-06
00840456202678JMU233010032026-07-06
00840456203019JMU390010052026-07-06
00840456203026JMU390010062026-07-06
00840456203033JMU390010072026-07-06
00840456203040JMU390010082026-07-06
00840456203057JMU390010092026-07-06
00840456203064JMU390010102026-07-06
00840456203071JMU390010112026-07-06
00840456203088JMU390010122026-07-06
00840456203095JMU390010132026-07-06
00840456206362JMU130100132026-07-06
00840456214305JMU130040052026-07-06
00840456214312JMU130040042026-07-06
00840456214329JMU130080012026-07-06
00840456214336JMU130090022026-07-06
00840456214343JMU130100112026-07-06
00840456214350JMU130100102026-07-06
00840456214367JMU130100092026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842942017537PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
00842942007828PRIMEDpriMED Medical Products IncFME2025-07-21
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00842942009341PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009358PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009365PRIMEDpriMED Medical Products IncFME2025-07-21
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00842942009556PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009563PRIMEDpriMED Medical Products IncFME2025-07-21
00842942013928PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014475PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014482PRIMEDpriMED Medical Products IncFME2025-07-21
00842942016080PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524410PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524441PRIMEDpriMED Medical Products IncFME2025-07-15
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15