FDA.reportPublic FDA data

hailie - For use only with Serevent HFA

Primary DI
09421032180231
Brand
hailie - For use only with Serevent HFA
Company
ADHERIUM (NZ) LIMITED
Model
NF0091
Device description
Non-rechargeable Battery
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421032180231PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421032180231094210321802319421032180231

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
+64093205093support@smartinhaler.com

Regulatory Flags#

DUNS number
590654401
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421032180279Hailie Sensor - for use only with Symbicort MDINF00922018-05-22
09421032180286Hailie Sensor - for use only with Bevespi AerosphereNF00962019-06-12
09421032180323Hailie Sensor - for use only with DiskusNF01002020-11-19
09421032180422Hailie Sensor - for use only with Symbicort MDINF01092021-12-02
09421032180439Hailie Sensor - for use only with ProAir HFANF01102023-10-10
00942103218039Hailie Sensor - for use only with Ellipta DPINF01102022-11-14
09421032180385Hailie Sensor - for use only with Ellipta DPINF01062022-11-14
09421032180408Hailie Sensor - for use only with Symbicort MDINF01072022-11-14
09421032180415Hailie Sensor - for use only with Symbicort MDINF01082022-11-14
09421032180330Hailie Sensor - for use only with HandiHalerNF01012021-11-25
09421032180095Hailie Sensor - for use only with Advair HFANF00902018-05-22
09421032180101Hailie Sensor - for use only with Flovent HFANF00902018-05-22
09421032180071Hailie Sensor - for use only with Ventolin HFANF00902018-05-22
09421032180163Hailie Sensor - for use only with ProAir HFANF00902018-05-22
09421032180170Hailie Sensor - for use only with Ventolin HFANF00912016-09-26
09421032180262Hailie Sensor - for use only with ProAir HFANF00912016-09-24
09421032180156Hailie Sensor - for use only with QVAR HFANF00902018-05-22
09421032180194Hailie Sensor - for use only with Advair HFANF00912016-09-24
09421032180200Hailie Sensor - for use only with Flovent HFANF00912016-09-24
09421032180255Hailie Sensor - for use only with QVAR HFANF00912016-09-24

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
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
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07