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AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable 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
- Primary DI / UDI-DI
- 00762860055414 FDA UDI
- 510(k) Number
- K053605 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
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
Category: Nebulizing system delivery set, reusable
AEROECLIPSE II Breath Actuated Nebulizer with Universal Tubing by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID
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
K053605 also covers:
- AEROECLIPSE II Breath Actuated Nebulizer Disposable — Trudell Medical International
- AEROECLIPSE II Breath Actuated Nebulizer Disposable with Elbow Adapter — Trudell Medical International
- AEROECLIPSE II Breath Actuated Nebulizer without Oxygen Tubing — Trudell Medical International
- AEROECLIPSE II Elbow Adapter for Breath Actuated Nebulizer Disposable — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Trudell Medical International
Sources (1)
- FDA UDI 7e5d16c9-240c-4f63-a59c-d9f74499f631 35 fields · synced May 30, 2026