FDA UDI
Not in Commercial Distribution
🇺🇸 United States
OMBRA 120V Table Top Compressor System
DI: 62860105510022
·
Model: 105510
·
Trudell Medical International
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- OMBRA 120V Table Top Compressor System
- Primary DI
- 62860105510022
- Version / Model
- 105510
- Catalog Number
- 10551094006
- Company Name
- Trudell Medical International
- Labeler DUNS
- 203298203
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2020-04-23
- Public Version Status
- Update
- Public Device Record Key
- 837b4980-861d-4db3-b0bf-bb3016f3c266
- Distribution End Date
- 2020-04-22
Device Description
OMBRA Table Top Compressor System (120V)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTI | Compressor, Air, Portable | Anesthesiology | 868.6250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31253 | Medical device air compressor | A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 62860105510022 | GS1 | ||||
| Unit of Use | 62860105510015 | GS1 |
Customer Contacts
- Phone
- 1-519-455-4862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131881 | 000 |