Hailie Sensor - for use only with ProAir HFA

GUDID 09421032180439

Inhaler dose sensor for ProAir HFA

ADHERIUM (NZ) LIMITED

Inhaler dose sensor
Primary Device ID09421032180439
NIH Device Record Keyab46d38b-8986-4fa7-8fa9-38781f3692a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameHailie Sensor - for use only with ProAir HFA
Version Model NumberNF0110
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
GS109421032180439 [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 Date2023-10-18
Device Publish Date2023-10-10

On-Brand Devices [Hailie Sensor - for use only with ProAir HFA]

94210321800572Non-rechargeable battery
94210321800466Rechargeable battery
09421032180439Inhaler dose sensor for ProAir HFA

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