Fisher and Paykel Healthcare

FDA UDI

Class I (US FDA UDI)

by Fisher & Paykel Healthcare, Inc.

Identity

Trade Name: Fisher and Paykel Healthcare FDA UDI
Generic Name: Nasal oxygen cannula, basic FDA UDI
Device Name: Optiflow Junior Premature Nasal Cannula FDA UDI
Model / Reference: OPT312 FDA UDI
Description: Optiflow Junior Premature Nasal Cannula FDA UDI

Identifiers

Catalog Number: OPT312 FDA UDI
Primary DI / UDI-DI: 09420012432278 FDA UDI
FDA Product Code: CAT FDA UDI
GMDN Term: Nasal oxygen cannula, basic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5340 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Nasal oxygen cannula, basic

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

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Fisher & Paykel Healthcare, Inc.

Sources (1)

FDA UDI 053d2b39-5a62-41ea-89dc-b38781b4a816 36 fields · synced May 30, 2026