CLEARLINK/DUO-VENT ACT8419

GUDID 50085412079757

Solution Set with DUO-VENT Spike, Luer Activated Valve Male Luer Lock Adapter with Retractable Collar

BAXTER INTERNATIONAL INC.

Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• Primary Device ID: 50085412079757
• NIH Device Record Key: 871afa53-bb85-4603-b252-d0901ba3ec34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARLINK/DUO-VENT
• Version Model Number: ACT8419
• Catalog Number: ACT8419
• Company DUNS: 005146311
• Company Name: BAXTER INTERNATIONAL 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412079752 [Primary]
GS1	50085412079757 [Package]; Contains: 00085412079752; Package: CASE [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112893

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-11
• Device Publish Date: 2016-09-24

On-Brand Devices [CLEARLINK/DUO-VENT]

• 50085412565755: Non-DEHP Solution Set with DUO-VENT Spike, 0.2 Micron Downstream Filter, Luer Activated Valve Ma
• 50085412565632: Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segment, Luer Activat
• 50085412079757: Solution Set with DUO-VENT Spike, Luer Activated Valve Male Luer Lock Adapter with Retractable C
• 50085412049101: Non-DEHP, Secondary Medication Set with DUO-VENT Spike, Hanger, Male Luer Lock Adapter
• 50085412048951: Solution Set with DUO-VENT Spike, Luer Activated Valve, Male Luer Lock Adapter with Retractable
• 50085412048548: Non-DEHP, Secondary Medication Set with DUO-VENT Spike, Hanger, Male Luer Lock Adapter
• 50085412048494: Non-DEHP Solution Set with DUO-VENT Spike, 0.2 Micron Downstream Filter, Luer Activated Valve, M
• 50085412048470: Secondary Medication Set with DUO-VENT Spike, Hanger, Male Luer Lock Adapter
• 50085412046384: Solution Set with DUO-VENT Spike, Polyethylene Lined Tubing, Non-DEHP Pump Segment, Luer Activat
• 50085412046360: Nitroglycerin Set with DUO-VENT Spike, PVC Tubing Segment, Luer Activated Valve, Male Luer Lock