Sof-Flo Atraumatic Coronary Artery Shunt

GUDID 00899054002753

Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft

KDL MEDICAL, INC.

Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt Surgical intravascular shunt

Primary Device ID	00899054002753
NIH Device Record Key	2280f9f5-9697-41b5-980e-5ff45241c9d9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Sof-Flo Atraumatic Coronary Artery Shunt
Version Model Number	SHT-1223S
Company DUNS	791048924
Company Name	KDL MEDICAL, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com
Phone	972-783-7005
Email	regulatory@chasemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899054002753 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K972665

FDA Product Code

DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-06
Device Publish Date	2024-04-26

On-Brand Devices [Sof-Flo Atraumatic Coronary Artery Shunt]

00899054002609	Vessel Shunt 2.50mm Tapered Tip, 12mm Shaft, ST
00899054002593	Vessel Shunt 2.00mm Tapered Tip, 12mm Shaft, ST
00899054002586	Vessel Shunt 1.75mm Tapered Tip, 12mm Shaft, ST
00899054002579	Vessel Shunt 1.50mm Tapered Tip, 12mm Shaft, ST
00899054002562	Vessel Shunt 1.25mm Tapered Tip, 12mm Shaft, ST
00899054002555	Vessel Shunt 1.00mm Tapered Tip, 12mm Shaft, ST
00899054002760	Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft, ST
00899054002753	Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft