FDA.reportPublic FDA data

JEDMED

Primary DI
M6330355460
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
03-5546
Catalog number
03-5546
Device description
Pressure System Pkg w/ Devilbiss
Published
2018-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
M6330355460PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
314-848-3770info@jedmed.com

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
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

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
M6334801800JEDMEDJEDMED INSTRUMENT COMPANYJPW2023-05-09
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
M6330355470JEDMEDJEDMED INSTRUMENT COMPANYJPW2018-07-13