CT Expres™ 3D

Basic Information

• Brand Name: CT Expres™ 3D
• Primary DI: 47630039300096
• Version / Model: 651207
• Catalog Number: 651207
• 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: 1afe358d-4cc3-4341-9dd9-1fe4a0003159

Device Description

Composed of : 1 x CT Exprès™ - Injector Unit GTIN : 37630039300105 2 x CT Exprès™ - Control Panel GTIN : 37630039300112

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
58000	CT 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 computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). 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 CT studies, and is stationary (e.g., fixed to a room rack). The system may synchronize media delivery with the x-ray generator during CT scanning.	No	Active
57999	CT 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 computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). 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 CT studies, and is mobile (e.g., on a wheeled pedestal). The system may synchronize media delivery with the x-ray generator during CT scanning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	47630039300096	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K151048	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Dry Environment
• Type: Handling Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity