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Hailie Sensor - for use only with Bevespi Aerosphere

FDA UDI

Class II (US FDA UDI)

by Adherium (Nz), Ltd.

Identity

Trade Name
Hailie Sensor - for use only with Bevespi Aerosphere FDA UDI
Generic Name
Inhaler dose sensor FDA UDI
Device Name
Non-rechargeable battery FDA UDI
Model / Reference
NF0096 FDA UDI
Description
Non-rechargeable battery FDA UDI

Identifiers

Primary DI / UDI-DI
09421032180286 FDA UDI
510(k) Number
K181405 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Inhaler dose sensor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Inhaler dose sensor

Hailie Sensor - for use only with Bevespi Aerosphere by Adherium (Nz), Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inhaler dose sensor.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Adherium (Nz), Ltd.

Sources (1)

  • FDA UDI 6f627154-b75a-4868-8204-f402ff1eb9a1 34 fields · synced May 30, 2026