Identity
- Trade Name
- DeVilbiss iFill FDA UDI
- Generic Name
- Oxygen compressor, home-use FDA UDI
- Device Name
- Portable Oxygen Station FDA UDI
- Model / Reference
- 535D FDA UDI
- Description
- Portable Oxygen Station FDA UDI
Identifiers
- Catalog Number
- 535D FDA UDI
- Primary DI / UDI-DI
- 00885304000853 FDA UDI
- 510(k) Number
- K053240 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Oxygen compressor, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5440 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Oxygen compressor, home-use
DeVilbiss iFill by DeVilbiss Healthcare LLC. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Oxygen compressor, home-use.
- MEDLINE UNITE — MEDLINE INDUSTRIES, INC. · Class I
- HomeFill® Oxygen System — VENTEC LIFE SYSTEMS, INC. · Class II
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 |
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Manufacturer
- Manufacturer
- DeVilbiss Healthcare LLC.
Sources (1)
- FDA UDI 371af944-ad51-4553-823c-cbfed48fa958 37 fields · synced Jun 1, 2026