ARROW

Basic Information

• Brand Name: ARROW
• Primary DI: 00801902008749
• Version / Model: IPN000106
• Catalog Number: AI-07368-NHF
• 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: 12
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 19ff6d7a-a14a-417d-937b-2ca75eec7bfe

Device Description

Thermodilution Balloon Catheter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
DYG	CATHETER, FLOW DIRECTED	Cardiovascular	870.1240	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34925	Pulmonary artery balloon catheter, electrical	A flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801902008749	GS1
Package	60801902008741	GS1	Case	5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	110	Centimeter
Catheter Gauge	7	French

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at normal room temperature away from direct exposure to light. Prolonged exposure to fluorescent light, sunlight or heat will damage the balloon