Identity
- Trade Name
- Ace Aerosol Cloud Enhancer FDA UDI
- Generic Name
- Atomizer, non-ventilatory FDA UDI
- Device Name
- The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery. FDA UDI
- Model / Reference
- 49502-203-01 FDA UDI
- Description
- The Aerosol Cloud Enhancer is designed to permit use in a vent circuit, an inceptive spirometer, in conjuction with an endotracheal airway or resuscitation bag and in routine oral inhalation. It has a coneshaped chamber intended to maximize respirable volume. The ACE masks attach and detach easily for MDI delivery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00349502203015 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Atomizer, non-ventilatory 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
Yes
FDA UDI
Category: Atomizer, non-ventilatory
Ace Aerosol Cloud Enhancer by Mylan Specialty L.P. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mylan Specialty L.P.
Sources (1)
- FDA UDI a926b9b6-3690-426b-88f7-cf9723305146 34 fields · synced May 30, 2026