Hailie Sensor - for use only with Flovent HFA

GUDID 94210321800503

Non-rechargeable battery

ADHERIUM (NZ) LIMITED

Inhaler dose sensor
Primary Device ID94210321800503
NIH Device Record Key289914a4-39f9-4814-9d42-b551f3cdfc39
Commercial Distribution StatusIn Commercial Distribution
Brand NameHailie Sensor - for use only with Flovent HFA
Version Model NumberNF0091
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 Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone1 (833) 886 9688
Emailsupport@hailie.com
Phone1 (833) 886 9688
Emailsupport@hailie.com

Device Identifiers

Device Issuing AgencyDevice ID
GS194210321800503 [Primary]

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-06-12
Device Publish Date2016-09-24

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

94210321800503Non-rechargeable battery
94210321800398Rechargeable battery
09421032180200Non-rechargeable battery

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