FDA.reportPublic FDA data

Proneb Max

Primary DI
00744229130017
Brand
Proneb Max
Company
PARI RESPIRATORY EQUIPMENT, INC.
Model
130F35-LCS
Catalog number
na
Device description
Proneb Max, 5 Yr, LC Sprint
Published
2020-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191270000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191270000Proneb MaxPari Respiratory Equipment, Inc.2020-01-23CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00744229100706PackageGS16In Commercial Distribution
00744229130017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00744229100706007442291007067442291007060744229100706
00744229130017007442291300177442291300170744229130017

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, reusableA collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.

Regulatory Flags#

DUNS number
804736098
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00744229440796Adult Aerosol Mask044F72522025-03-21
00744229440857Vortex044F81002024-04-30
00744229440864Vortex044F82002024-04-30
00744229100850Vortex044F81002024-04-30
00744229100867Vortex044F82002024-04-30
00744229510475Vortex051F80002024-04-26
00744229510529Vortex051F80002024-04-26
00744229510482Vortex051F81002024-04-23
00744229510499Vortex051F82002024-04-23
00744229510505Vortex051H84002024-04-23
00744229510581Vortex051F83002024-04-23
00744229510536Vortex051F81002024-04-23
00744229510543Vortex051F82002024-04-23
00744229510512Vortex051H84002024-04-23
00744229510598Vortex051F83002024-04-23
00744229230205LC Sprint Star023F41na2023-08-10
00744229440703Wing Tip044E00552023-06-28
00744229100706Proneb Max130F35-LCSna2020-05-22
00744229440840Bubbles044F72542023-04-13
00744229470076Trek S047F00202016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10197344135585MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154180MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07