CT Exprès™ - Hand Switch

Basic Information

• Brand Name: CT Exprès™ - Hand Switch
• Primary DI: 17630039300200
• Version / Model: 640080
• Catalog Number: 640080
• 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: 9c029287-5430-4dc9-b674-300d631547f9

Device Description

1 x CT Exprès™ - Hand Switch in packaging GTIN : 37630039300105

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: No
• Has Lot/Batch Number: Yes
• 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
36968	Contrast medium injection system control unit	A mains electricity (AC-powered) electronic device that may be a component of a contrast medium injector system and designed to initiate and terminate the operation of a contrast medium injection procedure from a remote location (e.g., the shielded operators control room).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17630039300200	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151048	000