ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902117806
• Version / Model: IPN037029
• Catalog Number: ASK-04020-SJF
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 8
• Public Version Date: 2022-05-13
• Public Version Status: Update
• Public Device Record Key: c1fb3e4e-547d-43e0-99bc-988e1085f05b

Device Description

Radial Artery Catheterization Kit with Integral Needle Protection

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
DQX	WIRE, GUIDE, CATHETER	Cardiovascular	870.1330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64575	Peripheral artery cannula	A short, thin tube intended for short-term (<= 30 days) percutaneous access to a peripheral artery for invasive blood pressure monitoring and arterial blood sampling; it may in addition be intended for peripheral IV and/or subcutaneous administration of fluid/medication. Also referred to as a peripheral arterial catheter, it is used with an external blood pressure transducer (not included) to enable pressures to be measured; it does not include electronic sensors and is not intended for thermal dilution techniques. It may include devices dedicated to introduction/function (e.g., introducer needle, guidewire, adaptor). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40801902117807	GS1	Case	5	Not in Commercial Distribution	2022-03-01
Primary	10801902117806	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K810675	000

Storage Conditions

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