Identity
- Trade Name
- MISTIC FDA UDI
- Generic Name
- Heated respiratory humidifier FDA UDI
- Device Name
- HUMIDIFIER FDA UDI
- Model / Reference
- P3500 FDA UDI
- Description
- HUMIDIFIER FDA UDI
Identifiers
- Catalog Number
- P3500 FDA UDI
- Primary DI / UDI-DI
- 00612223035013 FDA UDI
- 510(k) Number
- K894000 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 12 Inch FDA UDIHeight — 4.5 Inch FDA UDIOuter Diameter — 4.125 Inch FDA UDI
Category: Heated respiratory humidifier
Mistic by Pegasus Research Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Heated respiratory humidifier.
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- A Series Heated Humidifier — Respironics, Inc. · Class II
- HUDSON RCI — TELEFLEX INCORPORATED · Class II
Cleared under the same submission
K894000 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
- Pegasus Research Corp.
Sources (1)
- FDA UDI fed9f84f-93e9-4a76-81f7-cc2fb0183869 36 fields · synced Jun 8, 2026