Identity
- Trade Name
- OMBRA 120V Table Top Compressor System FDA UDI
- Generic Name
- Medical device air compressor FDA UDI
- Device Name
- OMBRA Table Top Compressor System (120V) FDA UDI
- Model / Reference
- 105510 FDA UDI
- Description
- OMBRA Table Top Compressor System (120V) FDA UDI
Identifiers
- Catalog Number
- 10551094006 FDA UDI
- Primary DI / UDI-DI
- 62860105510022 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
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
OMBRA 120V Table Top Compressor System by Trudell Medical International — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K131881 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Trudell Medical International
Sources (2)
- FDA UDI 837b4980-861d-4db3-b0bf-bb3016f3c266 37 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026