Identity
- Trade Name
- Humidx FDA UDI
- Generic Name
- Heat/moisture exchanger insertable filter FDA UDI
- Device Name
- HumidX 3PK FDA UDI
- Model / Reference
- 38809 FDA UDI
- Description
- HumidX 3PK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00619498388097 FDA UDI
- FDA Product Code
- BYD FDA UDI
- GMDN Term
- Heat/moisture exchanger insertable filter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5375 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
No
FDA UDI
Category: Heat/moisture exchanger insertable filter
Humidx by Resmed Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heat/moisture exchanger insertable filter.
- HumidX — Resmed Corp · Class I
- RespVent™ — CUTTING EDGE HC BRANDS LLC · Class II
- HYPO FILTER — Resmed Corp · Class II
- SPIRO — Fogless International AB · Class II
- DAR — Covidien LP · Class II
- HME Filters — CORVENT MEDICAL, INC · Class II
- BV Filters — CORVENT MEDICAL, INC · Class II
- Resp-O2 Advantage Filter- Universal Respiratory B/V Filter — Dynarex Corp. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Resmed Pty Ltd
Sources (1)
- FDA UDI e0584437-eeb7-4e7c-85e8-5373e984796d 34 fields · synced May 31, 2026