FDA.reportPublic FDA data

JEDMED

Primary DI
M6334801800
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
48-0180
Catalog number
48-0180
Device description
NEBULIZER GLASS COMPLETE
Published
2023-05-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JPWPump, Nebulizer, Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JPWPump, Nebulizer, Electrically PoweredEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6334801800PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Benchtop nebulizer, non-heatedAn assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978579510074ToTXinCareTongxin Home Care Industry (Shenzhen) Co., LimitedJPW2025-07-11
00604351707061Nasoneb®Monaghan Medical CorporationJPW2024-10-25
50604351707066Nasoneb®Monaghan Medical CorporationJPW2024-10-25
00604351350014Nasoneb®Monaghan Medical CorporationJPW2024-04-09
00604351707023Nasoneb®Monaghan Medical CorporationJPW2022-09-06
00604351707047Nasoneb®Monaghan Medical CorporationJPW2022-09-06
50604351707028Nasoneb®Monaghan Medical CorporationJPW2022-09-06
50604351707042Nasoneb®Monaghan Medical CorporationJPW2022-09-06
00604351707016Nasoneb®Monaghan Medical CorporationJPW2022-04-19
50604351707011Nasoneb®Monaghan Medical CorporationJPW2022-04-19
00372217005100Timmy the Tiger Pediatric NebulizerARISE MEDICAL LLCJPW2020-08-22
08018294012793FLAEM Rhino Clear SprintFLAEM NUOVA SPAJPW2020-07-10
00815027012185DALTON PULMOCARE COMPRESSOR NEBULIZER DALTON MEDICAL CORPORATIONJPW2020-05-25
00372217005025Procare Compact Compressor NebulizerARISE MEDICAL LLCJPW2018-12-21
M6330355460JEDMEDJEDMED INSTRUMENT COMPANYJPW2018-07-13
M6330355470JEDMEDJEDMED INSTRUMENT COMPANYJPW2018-07-13