Bulb Tip Coronary Artery Shunts

GUDID 00899054002616

Vessel Shunt 2.00mm Bulb Tip, 30mm Shaft

KDL MEDICAL, INC.

Surgical intravascular shunt

• Primary Device ID: 00899054002616
• NIH Device Record Key: 62b18fc8-47ff-404d-a354-e5a6ba31a3fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bulb Tip Coronary Artery Shunts
• Version Model Number: SHB-3020S
• 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: cust_svc@chasemedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00899054002616 [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: 2019-05-02
• Device Publish Date: 2019-04-24

Devices Manufactured by KDL MEDICAL, INC.

• 00899054002753 - Sof-Flo Atraumatic Coronary Artery Shunt: 2024-05-06 Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft
• 00899054002760 - Sof-Flo Atraumatic Coronary Artery Shunt: 2024-05-06 Vessel Shunt 2.25mm Tapered Tip, 12mm Shaft, ST
• 00899054002623 - Disposable Platform Blades: 2023-12-25 Disposable Platform Blades for Reusable Activator Drive
• 00899054002289 - Foot Pedal, Single Valve: 2021-10-27 Single Foot Valve for Stabilizer with Blower
• 00899054002067 - Mannequin™ Endoventricular Shaper: 2020-05-06 Mannequin™ Endoventricular Shaper, 80cc
• 00899054002098 - Mannequin™ Endoventricular Shaper: 2020-05-06 Mannequin™ Endoventricular Shaper, 90cc
• 00899054002111 - Mannequin™ Endoventricular Shaper: 2020-05-06 Mannequin™ Endoventricular Shaper, 100cc
• 00899054002142 - Mannequin™ Endoventricular Shaper: 2020-05-06 Mannequin™ Endoventricular Shaper, 110cc