ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 40801902111768
• Version / Model: IPN036186
• Catalog Number: CDC-12123-P1A
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-07
• Public Version: 8
• Public Version Date: 2024-01-11
• Public Version Status: Update
• Public Device Record Key: fe7fe7b2-f089-4cfa-96b0-aadb47899eac

Device Description

Pressure Injectable Three-Lumen Hemodialysis Catheterization for High Volume Infusions

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
NIE	CATHETER, HEMODIALYSIS, TRIPLE LUMEN, 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	30801902111761	GS1	Case	5	In Commercial Distribution
Primary	40801902111768	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K993933	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius