CLEARLINK 2R8403

GUDID 50085412656644

CLEARLINK System. Non-DEHP Solution Set with DUO-VENT Spike

BAXTER HEALTHCARE CORPORATION

Intravenous administration set

• Primary Device ID: 50085412656644
• NIH Device Record Key: 6972ccc6-9e9e-47c0-b43e-3e4bee3d0473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLEARLINK
• Version Model Number: 2R8403
• Catalog Number: 2R8403
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• 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
• 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	00085412656649 [Primary]
GS1	50085412656644 [Package]; Contains: 00085412656649; 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: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-05-31

Devices Manufactured by BAXTER HEALTHCARE CORPORATION

• 57332414208238 - ULTRACLAMP: 2025-02-18 UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Vantive Y-Set. The clamp is spec
• 50085412677762 - CLEARLINK/DUO-VENT: 2025-02-03 Non-DEHP Solution Set with DUO-VENT Spike, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 92" (2.3m) appr
• 50085412677786 - CLEARLINK/DUO-VENT: 2025-02-03 Non-DEHP Solution Set with DUO-VENT Spike, Luer Activated Valve, Male Luer Lock Adapter with Retractable Collar, 120" (3.05m) ap
• 50085412729188 - CLEARLINK/CONTINU-FLO/DUO-VENT: 2025-02-03 Non-DEHP CONTINU-FLO Solution Set with DUO-VENT Spike, 3 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar,
• 50085412729263 - CLEARLINK/CONTINU-FLO/DUO-VENT: 2025-02-03 Non-DEHP CONTINU-FLO Solution Set with DUO-VENT Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar,
• 35413765583422 - TISSEEL/ARTISS SPRAY SET: 2025-01-10 Tisseel/Artiss Spray Set 10 Pack
• 05413765852428 - Novum IQ: 2024-09-23 The Novum IQ Syringe Pump is software controlled Syringe infusion pump system that provides delivery of fluids into a patient
• 20085412676610 - DOSE IQ SAFETY SOFTWARE: 2024-09-02 Infusion Safety Management Software