Hailie Sensor - for use only with Symbicort MDI

GUDID 09421032180408

Inhaler dose sensor

ADHERIUM (NZ) LIMITED

Inhaler dose sensor
Primary Device ID09421032180408
NIH Device Record Keybfdfaf3e-ec21-4700-b9ef-8991b0056691
Commercial Distribution StatusIn Commercial Distribution
Brand NameHailie Sensor - for use only with Symbicort MDI
Version Model NumberNF0107
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
GS109421032180408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-11-22
Device Publish Date2022-11-14

On-Brand Devices [Hailie Sensor - for use only with Symbicort MDI]

94210321800589Non-rechargeable battery
09421032180422Inhaler dose sensor
09421032180415Inhaler dose sensor
09421032180408Inhaler dose sensor

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