FLOWMATE®

Basic Information

• Brand Name: FLOWMATE®
• Primary DI: 00801741067686
• Version / Model: INJ100
• Catalog Number: INJ100
• Company Name: Bard Peripheral Vascular, Inc.
• Labeler DUNS: 135057938
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 3
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: ae494685-05cf-42ac-a1c5-15df21356a50

Device Description

FLOWMATE® Injector

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXT	INJECTOR AND SYRINGE, ANGIOGRAPHIC	Cardiovascular	870.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57787	Atherectomy system saline/lubricant pump	A mains electricity (AC-powered) component of a mechanical atherectomy system designed to inject cooled normal sterile saline and/or surgical lubricant via the system’s dedicated catheter into the site of crossing a chronic partial occlusion (CPO) or chronic total occlusion (CTO) in both coronary and peripheral arteries. The device functions as a pump and will typically work in synchronization with the generator, whereby it may also function as the mains adaptor/control unit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00801741067686	GS1

Customer Contacts

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