MED-RX

Basic Information

• Brand Name: MED-RX
• Primary DI: 00628725003924
• Version / Model: 10-1257
• Catalog Number: 10-1257
• Company Name: Canadian Hospital Specialties Limited
• Labeler DUNS: 240992693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-18
• Public Version: 4
• Public Version Date: 2023-09-13
• Public Version Status: Update
• Public Device Record Key: 6d47e974-ff8c-46f7-868c-0cf311d5733b

Device Description

MED-RX I.V. ADMINISTRATION EXTENSION SET, 70" SET WITH 'Y'-TUBE & DUAL CHECK VALVE

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: No

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
12170	Intravenous administration tubing extension set	A collection of tubing and connectors intended to establish an extension of tubing where the standard length of the tubing in an intravenous (IV) administration set is insufficient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00628725003924	GS1
Package	50628725003929	GS1	CORRUGATE CASE	100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120375	000