← Back to catalogue
AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AEROECLIPSE XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- AEROECLIPSE XL Reusable Breath Actuated Nebulizer with AeroControl System Regulator (package of 10) FDA UDI
- Model / Reference
- 105507 FDA UDI
- Description
- AEROECLIPSE XL Reusable Breath Actuated Nebulizer with AeroControl System Regulator (package of 10) FDA UDI
Identifiers
- Catalog Number
- 10550794010 FDA UDI
- Primary DI / UDI-DI
- 62860105507022 FDA UDI
- 510(k) Number
- K080926 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 XL Reusable Breath Actuated Nebulizer w AeroControl System Regulator by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID
Cleared under the same submission
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 737b67ed-c22f-472b-8892-1b6bed12f60e 37 fields · synced May 29, 2026