FDA.reportPublic FDA data

Maxineb Duo

Primary DI
05055931118824
Brand
Maxineb Duo
Company
FLEXICARE MEDICAL LIMITED
Model
032-10-079U
Device description
MaxiNeb Duo Mouthpiece
Published
2024-03-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102719000ATLANTEAN TRIGGER NEBULIZERAtlantean Corporation2011-07-01CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055931118824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055931118824050559311188245055931118824

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, single-useA device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
504406273
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055931133858Reusable Angle Connector for CBS Bag Arm – Male to Male6002207-012026-07-21
05055931133865Reusable Angle Connector for CBS Bag Arm – Male to Female6002207-022026-07-21
05055788767640Leg Bag Holder Extra Large00-0038U2020-03-25
05055788767671Leg Bag Holder Large00-0037U2020-03-25
05055788767701Leg Bag Holder Medium00-0036U2020-03-25
05055788767732Leg Bag Holder Small00-0035U2020-03-25
05055788787044Flexicare040-11-0000U2026-03-31
05055788787068Flexicare040-12-0130U2026-03-31
05055788787082Flexicare040-12-0140U2026-03-31
05055788787105Flexicare040-12-2130U2026-03-31
05055788787129Flexicare040-12-2135U2026-03-31
05055788787143Flexicare040-12-2140U2026-03-31
05055788791317Flexicare030-620/1U2024-03-13
05055931101963Maxineb Duo Filter Pad032-10-021U2020-03-27
05055931101970Maxineb Duo032-10-031U2020-03-27
05055931101994Maxineb Duo Nebulizer + Mouthpiece032-10-033U2020-03-27
05055931102014Maxineb Duo Nebulizer + Mouthpiece And Filter032-10-034U2020-03-27
05055931102038Maxineb Duo Filter032-10-035U2020-03-27
05055931102052Maxineb Duo Filter Master Case032-10-036U2020-03-27
05055931102076Maxineb Duo Nebulizer And Tubing032-10-037U2020-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
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
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
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
00840117308695Resp-O2 Elite Compressor Nebulizer, Adult/PediatricDynarex CorporationCAF2022-05-11
00840117308718Resp-O2 Compact Compressor NebulizerDynarex CorporationCAF2022-05-11
00840117308732My Resp-O2 Bear Compressor NebulizerDynarex CorporationCAF2022-05-11
10888277657625MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699205MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699229MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699236MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.CAF2021-10-01
00888277692100MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-05-18