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Fisher & Paykel Healthcare

FDA UDI

Class II (US FDA UDI)

by Fisher & Paykel Healthcare, Inc.

Identity

Trade Name
Fisher & Paykel Healthcare FDA UDI
Generic Name
Professional high-flow respiratory unit, humidifying, manual FDA UDI
Device Name
myAIRVO 2 Humidifier Home US FDA UDI
Model / Reference
PT100US FDA UDI
Description
myAIRVO 2 Humidifier Home US FDA UDI

Identifiers

Catalog Number
PT100US FDA UDI
Primary DI / UDI-DI
09420012422248 FDA UDI
510(k) Number
K131895 FDA UDI
FDA Product Code
BTT FDA UDI
GMDN Term
Professional high-flow respiratory unit, humidifying, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5450 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

Yes

FDA UDI

Over-the-Counter

No

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Professional high-flow respiratory unit, humidifying, manual

Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Professional high-flow respiratory unit, humidifying, manual.

Cleared under the same submission

K131895 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fisher & Paykel Healthcare, Inc.

Sources (1)

  • FDA UDI 08f8d88a-997b-41f2-bfa3-5b8824acd54d 36 fields · synced Jun 6, 2026