Identity
- Trade Name
- OMBRA Compressor Air Filters FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- Compressor Air Filter Replacements to be used with OMBRA Compressor FDA UDI
- Model / Reference
- 105544 FDA UDI
- Description
- Compressor Air Filter Replacements to be used with OMBRA Compressor FDA UDI
Identifiers
- Catalog Number
- 10554494001 FDA UDI
- Primary DI / UDI-DI
- 62860105544027 FDA UDI
- 510(k) Number
- K131881 FDA UDI
- FDA Product Code
- BTI FDA UDI
- GMDN Term
- Medical device air compressor FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.6250 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
No
FDA UDI
Over-the-Counter
Yes
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
OMBRA Compressor Air Filters by Trudell Medical International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K131881 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 II | Pending data |
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Manufacturer
- Manufacturer
- Trudell Medical International
Sources (1)
- FDA UDI 77f3de87-839e-45b8-93a9-9c0823f0cdd7 37 fields · synced May 30, 2026