FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LF
DI: 10746190004110
·
Model: DL802001
·
Liebel-Flarsheim Company LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LF
- Primary DI
- 10746190004110
- Version / Model
- DL802001
- Company Name
- Liebel-Flarsheim Company LLC
- Labeler DUNS
- 080186051
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 6
- Public Version Date
- 2023-12-04
- Public Version Status
- Update
- Public Device Record Key
- 16aefe44-7dfe-4b73-837f-4aa8d5929055
- Distribution End Date
- 2022-03-07
Device Description
OptiStar LE MR Contrast Delivery System, Demo Loan
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 |
|---|---|---|---|---|
| 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 | 10746190004110 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K073592 | 000 |