MAHURKAR

Basic Information

• Brand Name: MAHURKAR
• Primary DI: 20884521058375
• Version / Model: 8888135139
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 10
• Public Version Date: 2023-11-09
• Public Version Status: Update
• Public Device Record Key: f4baed9f-3e3d-4cc4-897b-e7127f03ffe1

Device Description

Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC Components

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	876.5540	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46979	Double-lumen haemodialysis catheter, nonimplantable	A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20884521058375	GS1
Package	10884521519527	GS1	PACK_OR_INNER_PACK	15	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K030209	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	13.5	French
Length	13.5	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit