1/2'' x 3/8'' x 3/8'' Y Connector C-661

GUDID 16641670004182

This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.

Cardiomed Supplies Inc

Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile Low-pressure tubing connector, single-use, sterile

• Primary Device ID: 16641670004182
• NIH Device Record Key: f3cfea59-6f88-4ac1-9aac-f7347eb92ee4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1/2'' x 3/8'' x 3/8'' Y Connector
• Version Model Number: 2.8
• Catalog Number: C-661
• Company DUNS: 240623124
• Company Name: Cardiomed Supplies Inc
• Device Count: 50
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16641670004182 [Unit of Use]
GS1	36641670004193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K833112

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: 2020-12-10
• Device Publish Date: 2020-12-02

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• 16641670004168 - 3/8'' x 1/4'' x 3/8'' Y Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment
• 16641670004182 - 1/2'' x 3/8'' x 3/8'' Y Connector: 2020-12-10This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment that are utilized for this procedure.
• 16641670004182 - 1/2'' x 3/8'' x 3/8'' Y Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment
• 16641670004205 - 3/8'' x 1/4'' x 1/4'' Y Connector: 2020-12-10 This device is intended for use during cardiopulmonary bypass in conjunction with other medically approved devices and equipment