Hailie Sensor - for use only with Bevespi Aerosphere

GUDID 94210321800596

Non-rechargeable battery

ADHERIUM (NZ) LIMITED

Inhaler dose sensor
Primary Device ID94210321800596
NIH Device Record Key6f627154-b75a-4868-8204-f402ff1eb9a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameHailie Sensor - for use only with Bevespi Aerosphere
Version Model NumberNF0096
Company DUNS590654401
Company NameADHERIUM (NZ) LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS194210321800596 [Primary]

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-20
Device Publish Date2019-06-12

Devices Manufactured by ADHERIUM (NZ) LIMITED

09421032180439 - Hailie Sensor - for use only with ProAir HFA2023-10-18 Inhaler dose sensor for ProAir HFA
00942103218039 - Hailie Sensor - for use only with Ellipta DPI2022-11-22 Inhaler dose sensor
09421032180385 - Hailie Sensor - for use only with Ellipta DPI2022-11-22 Inhaler dose sensor
09421032180408 - Hailie Sensor - for use only with Symbicort MDI2022-11-22 Inhaler dose sensor
09421032180415 - Hailie Sensor - for use only with Symbicort MDI2022-11-22 Inhaler dose sensor
09421032180422 - Hailie Sensor - for use only with Symbicort MDI2021-12-10 Inhaler dose sensor
09421032180330 - Hailie Sensor - for use only with HandiHaler2021-12-03 Inhaler dose sensor
09421032180156 - Hailie Sensor - for use only with QVAR HFA2020-04-27 Rechargeable battery

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