ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902214239
• Version / Model: IPN927510
• Catalog Number: EDC-00622-HB
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-04-10
• Public Version: 2
• Public Version Date: 2024-01-10
• Public Version Status: Update
• Public Device Record Key: 5edfce4e-361c-4900-a06d-765545b1f704

Device Description

ARROW ENDURANCE(TM) Extended Dwell Peripheral Catheter System

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: 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
FOZ	Catheter, intravascular, therapeutic, short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801902214236	GS1	Case	5	In Commercial Distribution
Primary	10801902214239	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163513	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid freezing and excessive heat above 40C (104F).