ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 30801902123337
• Version / Model: IPN036420
• Catalog Number: CDC-02031-MK1A
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-08
• Public Version: 8
• Public Version Date: 2022-06-21
• Public Version Status: Update
• Public Device Record Key: 713d0531-d40d-4bea-8e5e-5312305f0731

Device Description

One-Lumen Midline

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: 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
LJS	Catheter,intravascular,therapeutic,long-term greater than 30 days	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64573	Peripheral intravenous catheterization kit	A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801902123330	GS1	Case	5	In Commercial Distribution
Primary	30801902123337	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K963257	000

Storage Conditions

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