Identity
- Trade Name
- Vixone Reusable Nebulizer FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Device Name
- Aerosol Drug Delivery System, contains 1 reusable Vixone and 1 Nebulizer compressor FDA UDI
- Model / Reference
- 0398 FDA UDI
- Description
- Aerosol Drug Delivery System, contains 1 reusable Vixone and 1 Nebulizer compressor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00709078004605 FDA UDI
- 510(k) Number
- K800562 FDA UDI
- FDA Product Code
- BTI FDA UDICAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.6250 FDA UDI868.5630 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nebulizing system delivery set, reusable
Vixone Reusable Nebulizer by Westmed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nebulizing system delivery set, reusable.
- Omron Nosepiece for Nebulizer — Omron Healthcare, Inc. · Class II
- Nasoneb® — MONAGHAN MEDICAL CORP. · Class I
- Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Schuco — Allied Medical LLC · Class II
- Yirdoc — Qingdao Future Medical Technology Co., Ltd. · Class II
- Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC. · Class II
Cleared under the same submission
K800562 also covers:
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC.
- Curaplex — TRI-ANIM HEALTH SERVICES, INC.
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
- Westmed, Inc.
Sources (1)
- FDA UDI f6ae46aa-9fc6-4cbd-8297-46f3f5de04e8 34 fields · synced May 30, 2026