Sof-Flo Atraumatic Coronary Artery Shunt

GUDID 00899054002586

Vessel Shunt 1.75mm Tapered Tip, 12mm Shaft, ST

KDL MEDICAL, INC.

Surgical intravascular shunt

• Primary Device ID: 00899054002586
• NIH Device Record Key: e3a8e0df-e551-46b3-830d-3ef8678dc8e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sof-Flo Atraumatic Coronary Artery Shunt
• Version Model Number: SHT-1218S-C01
• 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	00899054002586 [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

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