Identity
- Trade Name
- DRIVEMEDICAL FDA UDI
- Generic Name
- Ultrasonic respiratory humidifier FDA UDI
- Device Name
- RespiratoryRespiratory Disposables Product Description: 16" HUMIDIFIER TUBING,50/CS FDA UDI
- Model / Reference
- HUM-TUB FDA UDI
- Description
- RespiratoryRespiratory Disposables Product Description: 16" HUMIDIFIER TUBING,50/CS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50822383527982 FDA UDI
- FDA Product Code
- KFZ FDA UDI
- GMDN Term
- Ultrasonic respiratory humidifier FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5460 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasonic respiratory humidifier
Drivemedical by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic respiratory humidifier.
- Ultrasonic Mini Nebulizer — HOME AIDE DIAGNOSTICS, INC. · 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
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 1bb8d142-f1f0-412a-b23a-20b1d0c575be 33 fields · synced Jun 8, 2026