H4i

FDA UDI

Class II (US FDA UDI)

by Resmed Corp

Identity

Trade Name: H4i FDA UDI
Generic Name: CPAP/BPAP nasal mask, reusable FDA UDI
Device Name: H4i for Stellar AMERICAS FDA UDI
Model / Reference: 24927 FDA UDI
Description: H4i for Stellar AMERICAS FDA UDI

Identifiers

Catalog Number: 24927 FDA UDI
Primary DI / UDI-DI: 00619498249275 FDA UDI
510(k) Number: K080131 FDA UDI
FDA Product Code: BZD FDA UDI
GMDN Term: CPAP/BPAP nasal mask, reusable 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

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: CPAP/BPAP nasal mask, reusable

H4i by Resmed Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as CPAP/BPAP nasal mask, reusable.

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Nasal-Aire — Innomed Technologies · Class II
ComfortGel Blue — Respironics, Inc. · Class II
Dream Wisp — Respironics, Inc. · Class II
ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
DreamWear Gel Pillow — Respironics, Inc. · Class II

Cleared under the same submission

K080131 also covers:

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: Resmed Corp

Sources (1)

FDA UDI 3926a7b3-9dcb-4b89-90d8-a8532d8dd20d 37 fields · synced Jun 6, 2026