FDA Registration
Active
🇺🇸 United States
Liebel-Flarsheim Company LLC
Reg #: 1518293
·
FEI: 1518293
·
Expires 2026
Products
5
Proprietary Names
13
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- Liebel-Flarsheim Company LLC
- Registration Number
- 1518293
- FEI Number
- 1518293
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2111 EAST GALBRAITH RD.
- City
- Cincinnati
- State
- OH
- ZIP
- 45237
- Country
- US
Regulatory Submissions
- 510(k) Number
- K882329
Owner / Operator
- Firm Name
- Guerbet LLC / Liebel-Flarsheim Company LLC
- Operator Number
- 10050387
- Address
- 214 Carnegie Center, Suite 300
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2015-11-13 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2016-01-15 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2025-04-30 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2016-06-20 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2022-06-17 |
Proprietary Names
L-F Coiled Extension Tubing
Angiomat Illumena
OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspension; Injector, OptiOne Base System
OptiStar MR Injector System
Qitexio 4-Way Stopcock
OptiVantage DH Power Injection System
OptiVantage DH Injector System with Enhanced Communication
OptiStar Elite Injection System
Remote Stand
Disposable Syringe Fill Tube
Qitexio Luer Lock Syringes
Ready-Box Body-Temp Media Warmer
Angiomat 6000
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198