FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDRAD® Spectris MR Injection System
DI: 00616258010533
·
Model: SBP 200
·
BAYER MEDICAL CARE INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MEDRAD® Spectris MR Injection System
- Primary DI
- 00616258010533
- Version / Model
- SBP 200
- Catalog Number
- SBP 200
- Company Name
- BAYER MEDICAL CARE INC.
- Labeler DUNS
- 058716649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-22
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 6600d713-130e-4288-af13-6b877ef430cf
Device Description
INDIVIDUAL BATTERY PACK (59919044)
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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46592 | MRI contrast medium injection system, battery-powered | 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 battery-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 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 | 00616258010533 | GS1 |
Customer Contacts
- Phone
- +1(800)633-7231
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K935668 | 000 |