Identity
- Trade Name
- DRIVE FDA UDI
- Generic Name
- Aerosol face mask, non-rebreathing FDA UDI
- Device Name
- Respiratory Respiratory Disposables Product Description Pedi Ox Mask w/7'tub CS/50 FDA UDI
- Model / Reference
- MASK 003P FDA UDI
- Description
- Respiratory Respiratory Disposables Product Description Pedi Ox Mask w/7'tub CS/50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50822383132360 FDA UDI
- FDA Product Code
- KFZ FDA UDI
- GMDN Term
- Aerosol face mask, non-rebreathing 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Aerosol face mask, non-rebreathing
Drive by Drive Devilbiss Healthcare — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Aerosol face mask, non-rebreathing.
- Aerosol Masks — WESTMED, INC. · Class I
- BF — Allied Medical LLC · Class I
- Mask — WESTMED, INC. · Class I
- Mask — WESTMED, INC. · Class I
- MedSource Aerosol Mask — MEDSOURCE INTERNATIONAL LLC · Class I
- Curaplex — BOUND TREE MEDICAL, LLC · Class I
- AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
- AMSure® Aerosol Drainage System — AMSINO INTERNATIONAL, INC. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI 77e2018a-bbb2-43db-bb76-32f84c8b4717 33 fields · synced Jun 8, 2026