FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 08800019200055
·
Model: EPX-F5000
·
ECOTRON
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 08800019200055
- Version / Model
- EPX-F5000
- Catalog Number
- ECO-ER-CAT-001P
- Company Name
- ECOTRON
- Labeler DUNS
- 688209954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-28
- Public Version
- 4
- Public Version Date
- 2020-11-16
- Public Version Status
- Update
- Public Device Record Key
- 9fb1cecc-2519-4563-bd39-8c1b014186e8
Device Description
Input Power: 200V~240V, 50/60Hz Output Power: 5.0kW KVP range: 50~110kV mA range: 20~100mA mAs range: 0.4~100mAs X-ray Tube: OX/110-15 Focal Sport: 1.8 x 1.8mm Target Angle: 15 degrees Anode heat storage: 42kHU
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| IZL | System, X-Ray, Mobile | Radiology | 892.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37606 | Diagnostic x-ray system generator, portable | An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800019200055 | GS1 |
Customer Contacts
- Phone
- 9999999999
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 200 | Millimeter | |
| Height | 190 | Millimeter | |
| Length | 355 | Millimeter | |
| Weight | 13 | Kilogram |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 60 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 35 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius