CLS

GUDID 10864039000410

Saphenous Vein Cannula

COASTAL LIFE SYSTEMS, INC.

Vascular irrigation cannula, cardiac vessel graft

• Primary Device ID: 10864039000410
• NIH Device Record Key: c0a3fd1b-e430-40b0-9805-22a6a9141102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLS
• Version Model Number: 201006-000
• Company DUNS: 610391229
• Company Name: COASTAL LIFE SYSTEMS, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864039000413 [Primary]
GS1	10864039000410 [Package]; Contains: 00864039000413; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020768

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2018-06-19

On-Brand Devices [CLS]

• 10864039000410: Saphenous Vein Cannula
• 20864039000400: Insufflation Tubing Set