Identity
- Trade Name
- Ultrasonic Mini Nebulizer FDA UDI
- Generic Name
- Ultrasonic respiratory humidifier FDA UDI
- Device Name
- 12ml ultrasonic, portable, nonventilatory atomizer mini nebulizer FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 12ml ultrasonic, portable, nonventilatory atomizer mini nebulizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850027494364 FDA UDI
- FDA Product Code
- CCQ FDA UDI
- GMDN Term
- Ultrasonic respiratory humidifier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5640 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
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Ultrasonic respiratory humidifier
Ultrasonic Mini Nebulizer by Home Aide Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic respiratory humidifier.
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
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 |
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Manufacturer
- Manufacturer
- Home Aide Diagnostics, Inc.
Sources (1)
- FDA UDI 8b895f87-1b5a-4e74-8b42-3c04675e7682 34 fields · synced May 29, 2026