ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 00801902098252
• Version / Model: IPN032684
• Catalog Number: ASK-04000-PH
• 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: 11
• Public Version Date: 2023-07-18
• Public Version Status: Update
• Public Device Record Key: 1281b5e4-ecfa-4790-bd93-b7637148dd21

Device Description

Prep Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• 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: 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
DQY	CATHETER, PERCUTANEOUS	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61594	Central venous catheterization kit, short-term	A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, 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	30801902098253	GS1	Case	5	In Commercial Distribution
Primary	00801902098252	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K862056	000

Storage Conditions

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