FDA UDI
In Commercial Distribution
🇺🇸 United States
Remote Control
DI: 17630039302051
·
Model: 102409
·
Bracco Injeneering SA
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Remote Control
- Primary DI
- 17630039302051
- Version / Model
- 102409
- Company Name
- Bracco Injeneering SA
- Labeler DUNS
- 482489007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-29
- Public Version
- 1
- Public Version Date
- 2024-06-06
- Public Version Status
- New
- Public Device Record Key
- 84d9c06f-b99a-4417-826a-c0e50002e9e7
Device Description
EmpowerCTA+ Injector System, Remote Control
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
- 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 |
|---|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | Radiology | 892.1750 | 2 |
| IZQ | Injector, Contrast Medium, Automatic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58000 | CT contrast medium injection system, line-powered, stationary | An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of mains electricity (AC-powered) electromechanical injectors (electric motor connected to a jackscrew that moves a syringe piston) with syringes capable of delivering media with the pressure, flow range, and volume required for CT studies, and is stationary (e.g., fixed to a room rack). The system may synchronize media delivery with the x-ray generator during CT scanning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37630039302048 | GS1 | 1 | In Commercial Distribution | ||
| Primary | 17630039302051 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- dry environment