FDA UDI
In Commercial Distribution
🇺🇸 United States
OMBRA* Table Top Compressor System
DI: 00762860000582
·
Model: 105510
·
Trudell Medical International
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- OMBRA* Table Top Compressor System
- Primary DI
- 00762860000582
- Version / Model
- 105510
- Catalog Number
- 10551094006
- Company Name
- Trudell Medical International
- Labeler DUNS
- 203298203
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-06
- Public Version
- 1
- Public Version Date
- 2025-11-14
- Public Version Status
- New
- Public Device Record Key
- 89841e2c-125f-458d-8f40-d3f4f16e6a21
Device Description
Table Top Compressor System
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 | 00762860000582 | GS1 | ||||
| Package | 10762860000589 | GS1 | Retail Carton | 1 | In Commercial Distribution | |
| Package | 20762860000586 | GS1 | Outer Carton | 6 | In Commercial Distribution | |
| Previous | 00762860055100 | GS1 |
Customer Contacts
- Phone
- 1-519-455-4862
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K131881 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -13 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity