Bullfrog Micro-Infusion Device BF102R

GUDID M973BF102R1

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.

MERCATOR MEDSYSTEMS, INC.

Peripheral vascular infusion catheter
Primary Device IDM973BF102R1
NIH Device Record Key7b27fb4d-dfc8-45b7-81b8-c638bc74c67b
Commercial Distribution StatusIn Commercial Distribution
Brand NameBullfrog Micro-Infusion Device
Version Model NumberMDL09-2040-145-HT-R
Catalog NumberBF102R
Company DUNS103706391
Company NameMERCATOR MEDSYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com
Phone510-614-4550
Emailinfo@mercatormed.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM973BF102R1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRACatheter, Continuous Flush

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-16
Device Publish Date2020-04-08

On-Brand Devices [Bullfrog Micro-Infusion Device]

M973BF102S1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF102M1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF102L1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF101S1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF101M1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF101L1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF102R1The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, endovascular catheter t
M973BF102P18The Mercator MedSystems® Bullfrog® Micro-Infusion Device is a wire-guided, endovascular cathet

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