Bullfrog Micro-Infusion Device

Basic Information

• Brand Name: Bullfrog Micro-Infusion Device
• Primary DI: M973BF101M1
• Version / Model: MDL12-3060-145
• Catalog Number: BF101M
• Company Name: MERCATOR MEDSYSTEMS, INC.
• Labeler DUNS: 103706391
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-20
• Public Version: 7
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: fe8b8889-d249-45dd-90d5-4937104c3456
• Distribution End Date: 2018-10-03

Device Description

The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle. The needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.

Device Characteristics

• Single Use: Yes
• 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: 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
KRA	Catheter, Continuous Flush	Cardiovascular	870.1210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active
36205	Coronary artery infusion catheter	A sterile flexible tube, typically with a double-lumen, designed to access the coronary artery vasculature for local infusion of diagnostic or therapeutic solutions (e.g., angiographic contrast medium, heparin solution, saline), and often to function as a passage for a guidewire to assist its placement in the coronary artery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M973BF101M1	HIBCC

Customer Contacts

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