FDA.reportPublic FDA data

Hailie Sensor - for use only with Symbicort MDI

Primary DI
09421032180279
Brand
Hailie Sensor - for use only with Symbicort MDI
Company
ADHERIUM (NZ) LIMITED
Model
NF0092
Device description
Non-rechargeable battery
Published
2018-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163485000
K173310000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163485000SmartTouchAdherium (Nz), Ltd.2017-08-30CAF
K173310000SmartTouchAdherium (Nz), Ltd.2018-03-26CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421032180279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421032180279094210321802799421032180279

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.

Contacts#

Phone, Email table
PhoneEmail
1 (833) 886 9688support@hailie.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
09421032180231hailie - For use only with Serevent HFANF00912016-09-24
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

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