ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 10801902195118
• Version / Model: IPN920473
• Catalog Number: AO-09000
• Company Name: TELEFLEX INCORPORATED
• Labeler DUNS: 002348191
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-08
• Public Version: 2
• Public Version Date: 2023-07-19
• Public Version Status: Update
• Public Device Record Key: 23e87ebc-c05f-4953-9049-b2f0786ff5b0

Device Description

Hemostasis Valve Obturator 8 Fr. x .105" (2.67 mm) dia.

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
DYB	Introducer, catheter	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47766	Haemostasis valve obturator	A sterile device designed to seal the sheath of a haemostasis valve to maintain sheath patency (i.e., to prevent blood from coagulating in the sheath and blocking access through the haemostasis valve). It is typically a long, thin, rod-like device made of plastic with a rounded distal tip and a cap at the proximal end; it is available in a variety of sizes (e.g., 4-13 French and 15-26 cm long). The proximal cap has a locking mechanism (e.g., a Luer-lock or snap lock) to hold it securely in place to prevent blood loss from the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30801902195112	GS1	Case	2	In Commercial Distribution
Package	20801902195115	GS1	Box	25	In Commercial Distribution
Primary	10801902195118	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K780532	000