FDA UDI
In Commercial Distribution
🇺🇸 United States
EmpowerMR® Injector System without Remote Control
DI: 47630039300973
·
Model: 017377
·
Bracco Injeneering SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EmpowerMR® Injector System without Remote Control
- Primary DI
- 47630039300973
- Version / Model
- 017377
- Catalog Number
- 017377
- Company Name
- Bracco Injeneering SA
- Labeler DUNS
- 482489007
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-24
- Public Version
- 1
- Public Version Date
- 2019-06-03
- Public Version Status
- New
- Public Device Record Key
- 251b8285-5aa9-4ca7-8309-798d95e6f355
Device Description
Composed of: 1 x Hydraulic Controller 1 x Injector Head 1 x Electro-Hydraulic Interconnect
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 |
|---|---|---|---|---|
| IZQ | Injector, Contrast Medium, Automatic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58002 | MRI 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 magnetic resonance imaging (MRI) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using MRI). 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 MRI studies, and is stationary. It may interface with the MRI system or monitoring device to control timing of contrast injections; it is made entirely of non-ferromagnetically active materials for MRI compatiblity. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 47630039300973 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062449 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry environment