Identity
- Trade Name
- DeVilbiss FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- PULMO-AIDE FDA UDI
- Model / Reference
- 5650D FDA UDI
- Description
- PULMO-AIDE FDA UDI
Identifiers
- Catalog Number
- 5650D FDA UDI
- Primary DI / UDI-DI
- 00885304000877 FDA UDI
- 510(k) Number
- K923888 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Medical device air compressor 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical device air compressor
DeVilbiss by DeVilbiss Healthcare LLC. — 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
- DeVilbiss Healthcare LLC.
Sources (1)
- FDA UDI 68d67e14-a21f-4da4-bd3d-1be579b1074b 37 fields · synced Jun 7, 2026