AEROECLIPSE XL Reusable Breath Actuated Nebulizer

FDA UDI

Class II (US FDA UDI)

by Trudell Medical International

Identity

Trade Name: AEROECLIPSE XL Reusable Breath Actuated Nebulizer FDA UDI
Generic Name: Nebulizing system delivery set, reusable FDA UDI
Device Name: AEROECLIPSE XL Reusable Breath Actuated Nebulizer FDA UDI
Model / Reference: 105513 FDA UDI
Description: AEROECLIPSE XL Reusable Breath Actuated Nebulizer FDA UDI

Identifiers

Primary DI / UDI-DI: 00762860055131 FDA UDI
510(k) Number: K080926 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Nebulizing system delivery set, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Nebulizing system delivery set, reusable

AEROECLIPSE XL Reusable Breath Actuated Nebulizer by Trudell Medical International — 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
VixOne™ Reusable Nebulizer — WESTMED, INC. · Class II
Trek S — PARI RESPIRATORY EQUIPMENT, INC. · Class II

Cleared under the same submission

K080926 also covers:

EZ TWIST Tubing Replacement for AEROECLIPSE XL BAN — Trudell Medical International

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: Trudell Medical International

Sources (1)

FDA UDI baf6375f-fcc6-4f11-bd82-3719bae170b8 35 fields · synced May 30, 2026