Medex

Basic Information

• Brand Name: Medex
• Primary DI: 10351688507983
• Version / Model: MX377
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 828611934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3adf39cc-17fa-455f-9fd4-b1eeb69ca3b3

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40721	Manual contrast medium injection system	An assembly of devices designed for the manual-only injection of contrast media into the blood or lymphatic vessels of a patient for a diagnostic imaging procedure; it enables the operator to manually control the volume and rate of contrast media administered under pressure. The system typically consists of a graduated injection syringe, a manifold with multiple stopcocks, and a pressure transducer system used by the operator to monitor catheter-tip pressure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50351688507981	GS1	CASE	20	In Commercial Distribution
Primary	10351688507983	GS1

Premarket Submissions

Submission Number	Supplement Number
K883094	000