FDA UDI
In Commercial Distribution
🇺🇸 United States
MOBILE NANO
DI: 00885310000427
·
Model: VZW2566RTDM
·
Communications & Power Industries Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MOBILE NANO
- Primary DI
- 00885310000427
- Version / Model
- VZW2566RTDM
- Company Name
- Communications & Power Industries Canada Inc
- Labeler DUNS
- 202887311
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-24
- Public Version
- 2
- Public Version Date
- 2020-10-12
- Public Version Status
- Update
- Public Device Record Key
- a6b25679-7e19-456f-9a5e-940080f343c6
Device Description
Generator, High-Voltage, X-Ray, Diagnostic, MOBILE NANO, RAD, 8kW, 62-76V
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | Radiology | 892.1700 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37605 | Diagnostic x-ray system generator, mobile | An x-ray generator with special size, weight, and power requirements that makes it suitable for use in a mobile x-ray system, e.g., a system designed to be pushed or driven to various locations within a facility. 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). It includes transformer, inverter, and capacitor discharge generator designs. It typically comprises a control assembly (console) and high voltage transformer assembly or is of a mono-tank generator design. This generator is an integral component of a mobile diagnostic x-ray system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00885310000427 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 457.0 | Millimeter | |
| Height | 353.6 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 525 – 795 Millimeter of Mercury