FDA Registration
Active
🇺🇸 United States
E-Z-EM, INC.
Reg #: 2411512
·
FEI: 2411512
·
Expires 2026
Products
9
Proprietary Names
22
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- E-Z-EM, INC.
- Registration Number
- 2411512
- FEI Number
- 2411512
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 510 Carnegie Center
- City
- Princeton
- State
- NJ
- ZIP
- 08540
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181343
Owner / Operator
- Firm Name
- Bracco Diagnostics Inc.
- Operator Number
- 2411512
- Address
- 510 Carnegie Center
- City
- Princeton
- State
- NJ
- Postal Code
- 08540
- Country
- US
- Correspondent
- Elyssa - Murray
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Container, Liquid Medication, Graduated | KYW | Class 1 | General Hospital | No | 2004-08-24 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2019-05-07 |
| Urinal | FNP | Class 1 | General Hospital | No | 1992-08-18 |
| Container, Specimen, Sterile | FMH | Class 1 | Pathology | No | 1992-08-18 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2017-06-13 |
| Shield, Vial | IWW | Class 1 | Radiology | No | 2012-03-28 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2012-03-11 |
| Insufflator, Automatic Carbon-Dioxide For Endoscope | FCX | Class 2 | Gastroenterology, Urology | No | 2007-12-17 |
| Catheter, Retention, Barium Enema With Bag | FGD | Class 2 | Gastroenterology, Urology | No | 2005-03-21 |
Proprietary Names
LIQUID MEDICATION DISPENSER
HeartSee Cardiac P.E.T.Processing Software
CYSTO-AID (TM) VOIDING AID
CYSTO AID
Transpec Specimen Radiography Device
E-Z Mark
Vented Cap/Waste Bottle use with CardioGen-82 Infusion Syste
Waste Bottle for use with CardioGen-82 Infusion System
Elution Test Vial Bottle use with CardioGen-82 Infusion Syst
Elution Test Vial Shield use with CardioGen-82 Infusion Syst
Accessory Package for use with CardioGen-82 Infusion System
Patient Administration Set for CardioGen-82 Infusion System
Protocol Insufflator
VC Administration Kits
Protocol Touch Admininstration Set
Protocol Touch Colon Insufflator
BAGS
EMPTY ENEMA KITS
TIPS AND ACCESSORIES
TUBING
SUPER XL
CardioGen-82 Infusion System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility