Identity
- Trade Name
- AEROCHAMBER* MV Holding Chamber FDA UDI
- Generic Name
- Atomizer, ventilatory FDA UDI
- Device Name
- AEROCHAMBER* MV Holding Chamber FDA UDI
- Model / Reference
- 82591 FDA UDI
- Description
- AEROCHAMBER* MV Holding Chamber FDA UDI
Identifiers
- Catalog Number
- 825110050 FDA UDI
- Primary DI / UDI-DI
- 00762860000827 FDA UDI
- 510(k) Number
- K900557 FDA UDI
- FDA Product Code
- CCQ FDA UDI
- GMDN Term
- Atomizer, ventilatory FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5640 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: Atomizer, ventilatory
AEROCHAMBER* MV Holding Chamber by Trudell Medical International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Atomizer, ventilatory.
- MDHC — MDHC Life Technologies (Kunshan) Co., LTD. · Class I
Cleared under the same submission
K900557 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Trudell Medical International
Sources (1)
- FDA UDI 8e209644-3f0f-4444-b389-ff6849193c3e 36 fields · synced Jun 8, 2026