FDA UDI
In Commercial Distribution
🇺🇸 United States
EmpowerCTA+ Injector System
DI: 47630039301949
·
Model: 017285
·
Bracco Injeneering SA
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EmpowerCTA+ Injector System
- Primary DI
- 47630039301949
- Version / Model
- 017285
- Catalog Number
- 017285
- Company Name
- Bracco Injeneering SA
- Labeler DUNS
- 482489007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-05
- Public Version
- 1
- Public Version Date
- 2024-02-13
- Public Version Status
- New
- Public Device Record Key
- c88196e7-be8d-480a-882e-f1e64f9ca249
Device Description
Composed of : 1 x Remote Control 1 x EmpowerSync® Power Supply 1 x Injector
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
- MR Unsafe
- 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 |
| DSB | Plethysmograph, Impedance | Cardiovascular | 870.2770 | 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 |
|---|---|---|---|---|---|---|
| Primary | 47630039301949 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071378 | 000 |