MEDADV

Basic Information

• Brand Name: MEDADV
• Primary DI: 00819667020241
• Version / Model: M216
• Catalog Number: M216
• Company Name: MEDAS INC
• Labeler DUNS: 080593067
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-09
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: 9c8643af-3005-48e4-b5c5-18d14843a7f2

Device Description

HEMODIALYSIS CATHETER DOUBLE LUMEN 12 Fr X 20 CM

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: Yes
• 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
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61630	Haemodialysis/central venous catheterization kit	A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enabling central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes a nonimplantable triple-lumen haemodialysis catheter, devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10819667020248	GS1		10	In Commercial Distribution
Primary	00819667020241	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K102833	000