VixOne™ Reusable Nebulizer

FDA UDI

Class II (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: VixOne™ Reusable Nebulizer FDA UDI
Generic Name: Nebulizing system delivery set, reusable FDA UDI
Device Name: 1 reusable Vixone Super Spike Mask, 7' tubing, Pedi-Neb, nebulizer compressor FDA UDI
Model / Reference: 0397 FDA UDI
Description: 1 reusable Vixone Super Spike Mask, 7' tubing, Pedi-Neb, nebulizer compressor FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078004865 FDA UDI
FDA Product Code: OGG FDA UDI
GMDN Term: Nebulizing system delivery set, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

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Manufacturing Date

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

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 21f3877a-a913-49b4-bde4-3a412e598c81 33 fields · synced Jun 7, 2026