Identity
- Trade Name
- H4i FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- H4i WATER CHAMBER FDA UDI
- Model / Reference
- 26952 FDA UDI
- Description
- H4i WATER CHAMBER FDA UDI
Identifiers
- Catalog Number
- 26952 FDA UDI
- Primary DI / UDI-DI
- 00619498269525 FDA UDI
- 510(k) Number
- K080131 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Heated respiratory humidifier 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
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
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: Heated respiratory humidifier
H4i by Resmed Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heated respiratory humidifier.
- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- Fisher and Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
- A Series Heated Humidifier — Respironics, Inc. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · 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 e2ef6d6a-6df9-4267-8770-be9976c76b46 37 fields · synced Jun 8, 2026