Medex

Basic Information

• Brand Name: Medex
• Primary DI: 10351688516374
• Version / Model: 5360225
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 828611934
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 4ab0b9f9-9219-4a2c-9c93-eb3d51ae2792

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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59229	Hypodermic needle, single-use, non-sterile	A non-sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes, secondary medication sets, or phlebotomy equipment (e.g., blood collection adapters or holders) to prepare and administer fluids/medications/drugs to a patient and/or to withdraw (aspirate) fluids from a patient. This is a single-use device intended to be sterilized prior to end use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50351688516372	GS1	CASE	25	In Commercial Distribution
Primary	10351688516374	GS1