FDA.reportPublic FDA data

Hailie Sensor - for use only with QVAR HFA

Primary DI
94210321800565
Brand
Hailie Sensor - for use only with QVAR HFA
Company
ADHERIUM (NZ) LIMITED
Model
NF0091
Device description
Non-rechargeable battery
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

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
94210321800565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
9421032180056594210321800565

GMDN Terms#

Term, Definition table
TermDefinition
Inhaler dose sensorA small, non-sterile, battery-powered device intended to be attached to a portable inhaler [e.g., metered dose inhaler (MDI), dry powder inhaler (DPI), soft mist inhaler (SMI)] to detect when a dose of inhaled medication has been taken, and to transmit this data wirelessly to a separate device (e.g., smartphone with appropriate software) to evaluate dosing interval. It is typically used in conjunction with software that may, e.g., set reminders. This is a single-patient reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1 (833) 886 9688support@hailie.com

Regulatory Flags#

DUNS number
590654401
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421032180231hailie - For use only with Serevent HFANF00912016-09-24
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

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04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
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