FDA UDI
In Commercial Distribution
🇺🇸 United States
EmpowerMR® Injector System without Remote Control
DI: 47630039300751
·
Model: 017377
·
Bracco Injeneering SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EmpowerMR® Injector System without Remote Control
- Primary DI
- 47630039300751
- 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
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c008b92a-be34-4f06-8f94-1a7f970a5fa3
Device Description
Composed of : 1 x Electro-Hydraulic Interconnect GTIN : 37630039300365 1 x Hydraulic Controller GTIN : 37630039300389 1 x Injector Head GTIN : 37630039300396
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 |
|---|---|---|---|---|
| 58001 | MRI contrast medium injection system, line-powered, mobile | 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 (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for MRI studies, and is mobile. It may interface with the MRI system or a 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 | 47630039300751 | GS1 |
Customer Contacts
- Phone
- +41216236030
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K062449 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Dry environment