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AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing

FDA UDI

Class II (US FDA UDI)

by Trudell Medical International

Identity

Trade Name
AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing FDA UDI
Generic Name
Therapeutic agent nebulizer, benchtop FDA UDI
Device Name
AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing FDA UDI
Model / Reference
105541 FDA UDI
Description
AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing FDA UDI

Identifiers

Catalog Number
10554194050 FDA UDI
Primary DI / UDI-DI
62860105541026 FDA UDI
510(k) Number
K053605 FDA UDI
FDA Product Code
CAF FDA UDI
GMDN Term
Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5630 FDA UDI
Commercial Distribution
Not 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K053605 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trudell Medical International

Sources (1)

  • FDA UDI b6cb4922-88ba-4406-8925-5f9a2c74e48a 37 fields · synced May 29, 2026