ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 40801902134545
• Version / Model: IPN048795
• Catalog Number: UC-19611-KPU
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-09
• Public Version: 3
• Public Version Date: 2021-04-21
• Public Version Status: Update
• Public Device Record Key: dbc0d30b-3b35-4856-b45a-14e79429aa78

Device Description

UltraCath(TM) Continuous Nerve Block Kit

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: MR Unsafe
• Direct Marking Exempt: Yes
• 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
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30801902134548	GS1	Case	5	Not in Commercial Distribution	2021-04-15
Primary	40801902134545	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K162522	000