Identity
- Trade Name
- O2asis Humidifier FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- O2asis Humidifier Kit FDA UDI
- Model / Reference
- Humidifier Kit FDA UDI
- Description
- O2asis Humidifier Kit FDA UDI
Identifiers
- Catalog Number
- HU501 FDA UDI
- Primary DI / UDI-DI
- 00840106905492 FDA UDI
- 510(k) Number
- K193411 FDA UDI
- FDA Product Code
- BTT FDA UDI
- GMDN Term
- Heated respiratory humidifier FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5450 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Heated respiratory humidifier
O2asis Humidifier by Perma Pure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heated respiratory humidifier.
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- 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
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
- Perma Pure, LLC
Sources (1)
- FDA UDI 2afa9195-e92d-4e34-9451-5656fa0e6f1e 35 fields · synced May 30, 2026