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: Medical networking interface unit FDA UDI
Device Name: INFOSEND GSM - North America FDA UDI
Model / Reference: 900ICON500N FDA UDI
Description: INFOSEND GSM - North America FDA UDI

Identifiers

Catalog Number: 900ICON500N FDA UDI
Primary DI / UDI-DI: 09420012425218 FDA UDI
510(k) Number: K110316 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: Medical networking interface unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5905 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical networking interface unit

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

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Cleared under the same submission

K110316 also covers:

Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC.

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 II	Pending data

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Manufacturer

Manufacturer: Fisher & Paykel Healthcare, Inc.

Sources (1)

FDA UDI df8f5158-c859-47d8-95f5-e83c15da77ac 36 fields · synced May 30, 2026